Evercos Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)
For Evercos Co., Ltd., import alert is 66-41; country is KOREA (THE REPUBLIC OF); import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.
- 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
What the source says
Evercos Co., Ltd. Date Published : 09/28/2020 13 Hakpyeongpungjeong-Gil; Cheongwon , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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