Reference Source

Evercos Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)

For Evercos Co., Ltd. · 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 Kundal Dandruff Relief Shampoo | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Kundal Dandruff Relief Shampoo; product code is 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 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 - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 99 Anti-Microbial N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 09/28/2020; address is 13 Hakpyeongpungjeong-Gil; Cheongwon , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
Evercos Co., Ltd. verified
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
Address
13 Hakpyeongpungjeong-Gil; Cheongwon , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF) verified
Date published
09/28/2020 verified
Product code
53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 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 - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 62 H - - 99 Anti-Microbial N.E.C. | 64 A - - 99 Disinfectant N.E.C. | 65 L - - 99 Protectant N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Kundal Dandruff Relief Shampoo | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Pure Label Advanced Hand Sanitizer Gel Plus | Kundal Dandruff Relief Shampoo each item verified
FDA notes
The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Evercos Co., Ltd. Date Published : 09/28/2020 13 Hakpyeongpungjeong-Gil; Cheongwon , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF) 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 01/24/2025 Desc: Kundal Dandruff Relief Shampoo 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 62 H - - 99 Anti-Microbial N.E.C. Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 64 A - - 99 Disinfectant N.E.C. Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 65 L - - 99 Protectant N.E.C. Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/28/2020 Desc: Pure Label Advanced Hand Sanitizer Gel Plus Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... Proven to kill 99.9% of most illness causing germs without damaging skin ...' that are not in conformance with 'Topical Antimicrobial Drug Products for Over?the?Counter Human Use; Tentative Final Monograph for Health?Care Antiseptic Drug Products' or associated current guidance. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/24/2025 Desc: Kundal Dandruff Relief Shampoo

accessdata.fda.gov, retrieved 2026-09-15

Source

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