Taizhou Yadai Daily-Use Co., Ltd. · 66-41 · CHINA
For Taizhou Yadai Daily-Use Co., Ltd. · 66-41 · CHINA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CHINA; product is Al-kogel 75% Alcohol Antiseptic Gel; product code is 62 H - - 05 Ethyl Alcohol (Anti-Microbial); date published is 09/08/2020; address is Bldg 2 Fl. 2 , 95-1 Dongtaihe Rd; Jiaojiang District , Taizhou, Zhejiang CHINA, verified against its source on 2026-09-16.
- Firm
- Taizhou Yadai Daily-Use Co., Ltd. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- CHINA verified
- Address
- Bldg 2 Fl. 2 , 95-1 Dongtaihe Rd; Jiaojiang District , Taizhou, Zhejiang CHINA verified
- Date published
- 09/08/2020 verified
- Product code
- 62 H - - 05 Ethyl Alcohol (Anti-Microbial) verified
- Product
- Al-kogel 75% Alcohol Antiseptic Gel 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): '... for the sanitization and asepsis of hands and forearms. It provides an effective action against a wide range of microorganisms including bacteria, viruses and germs using mechanism of action of protein denaturation ...' 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. In addition, the product appears to be an unapproved new drug as the product label does not distinguish between active and inactive ingredients which makes all listed ingredients active ingredients which is 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
What the source says
Taizhou Yadai Daily-Use Co., Ltd. Date Published : 09/08/2020 Bldg 2 Fl. 2 , 95-1 Dongtaihe Rd; Jiaojiang District , Taizhou, Zhejiang CHINA 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 09/08/2020 Desc: Al-kogel 75% Alcohol Antiseptic Gel Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): '... for the sanitization and asepsis of hands and forearms. It provides an effective action against a wide range of microorganisms including bacteria, viruses and germs using mechanism of action of protein denaturation ...' 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. In addition, the product appears to be an unapproved new drug as the product label does not distinguish between active and inactive ingredients which makes all listed ingredients active ingredients which is 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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.