# COSMAX, INC. · 66-41 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For COSMAX, INC. · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Apple Mango | Vitapair C Dark Spot Cream | Vitapair C Dark Spot Serum with Dark Spot Cream Special Set | SUN SHIELD CAVA Sun Cream (SPF 50 ; PA) | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Peppermint | SUN SHIELD CAVA Sun Cream (SPF 50 ; PA) | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Grape | SUN SHIELD CAVA Sun Cream (SPF 50 ; PA ) | Hand&Nature Sanitizer Gel - Apple | SUN SHIELD CAVA Sun Cream (SPF 50 ; PA ) | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Lemon | Vitapair C Dark Spot Serum with Dark Spot Cream Special Set | Vitapair C Dark Spot Cream; product code is 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - -- Skin Care Prep | 53 L - - -- Skin Care Prep | 53 L - - -- Skin Care Prep | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/04/2013; address is 46 Jeyakgongdan2-Gil , Hyangnam-Eup, Manse-gu , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** COSMAX, INC. _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 46 Jeyakgongdan2-Gil , Hyangnam-Eup, Manse-gu , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 06/04/2013 _(verified: appears in the quote below)_
- **Product code:** 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - -- Skin Care Prep | 53 L - - -- Skin Care Prep | 53 L - - -- Skin Care Prep | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 62 H - - 99 Anti-Microbial N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Apple Mango | Vitapair C Dark Spot Cream | Vitapair C Dark Spot Serum with Dark Spot Cream Special Set | SUN SHIELD CAVA Sun Cream (SPF 50 ; PA) | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Peppermint | SUN SHIELD CAVA Sun Cream (SPF 50 ; PA) | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Apple | Hand&Nature Sanitizer Gel - Lemon | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Grape | SUN SHIELD CAVA Sun Cream (SPF 50 ; PA ) | Hand&Nature Sanitizer Gel - Apple | SUN SHIELD CAVA Sun Cream (SPF 50 ; PA ) | Hand&Nature Sanitizer Gel - Camellia | Hand&Nature Sanitizer Gel - Grape | Hand&Nature Sanitizer Gel - Peppermint | Hand&Nature Sanitizer Gel - Rose | Hand&Nature Sanitizer Gel - Apple Mango | Hand&Nature Sanitizer Gel - Lemon | Vitapair C Dark Spot Serum with Dark Spot Cream Special Set | Vitapair C Dark Spot Cream _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | Korea | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | Korea | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | Korea | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | Korea | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. | The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. _(verified: each item appears in the quote below)_

## What the source says

> COSMAX, INC. Date Published : 06/04/2013 46 Jeyakgongdan2-Gil , Hyangnam-Eup, Manse-gu , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF) 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 53 L - - -- Skin Care Prep Date Published: 08/06/2022 Desc: Vitapair C Dark Spot Cream 53 L - - -- Skin Care Prep Date Published: 08/06/2022 Desc: Vitapair C Dark Spot Serum with Dark Spot Cream Special Set 53 L - - -- Skin Care Prep Date Published: 06/04/2013 Desc: SUN SHIELD CAVA Sun Cream (SPF 50 ; PA) Notes: Korea 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 99 Anti-Microbial N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 99 Anti-Microbial N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 99 Anti-Microbial N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 99 Anti-Microbial N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 99 Anti-Microbial N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 99 Anti-Microbial N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 62 H - - 99 Anti-Microbial N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 64 A - - 99 Disinfectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 64 A - - 99 Disinfectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 64 A - - 99 Disinfectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 64 A - - 99 Disinfectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 64 A - - 99 Disinfectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 64 A - - 99 Disinfectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 64 A - - 99 Disinfectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 65 L - - 99 Protectant N.E.C. Date Published: 06/04/2013 Desc: SUN SHIELD CAVA Sun Cream (SPF 50 ; PA) Notes: Korea 65 L - - 99 Protectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 65 L - - 99 Protectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 65 L - - 99 Protectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 65 L - - 99 Protectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 65 L - - 99 Protectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 65 L - - 99 Protectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 65 L - - 99 Protectant N.E.C. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 66 P - - 99 Ultraviolet Screen/Sunscreen N.E.C. Date Published: 06/04/2013 Desc: SUN SHIELD CAVA Sun Cream (SPF 50 ; PA ) Notes: Korea 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/04/2013 Desc: SUN SHIELD CAVA Sun Cream (SPF 50 ; PA ) Notes: Korea 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Camellia Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Grape Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Peppermint Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Rose Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Apple Mango Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/28/2020 Desc: Hand&Nature Sanitizer Gel - Lemon Notes: The product appears to be an unapproved new drug as the product label identifies alcohol 54.72% as the active ingredient. The product is not consistent with the conditions proposed in the 1994 "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products" (or any of the amendments to the TFM) or to any temporary FDA policy that would permit its marketing without an approved application, because alcohol at 54.72% falls below what has been proposed as safe and effective. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/06/2022 Desc: Vitapair C Dark Spot Serum with Dark Spot Cream Special Set 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/06/2022 Desc: Vitapair C Dark Spot Cream

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).