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

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: 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:** 13 Hakpyeongpungjeong-Gil; Cheongwon , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 09/28/2020 _(verified: appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_

## 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

## 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/).