Daraeworld Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)
For Daraeworld 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 Jeopureun Chowon Wiae Hand Sanitizer; product code is 62 H - - 99 Anti-Microbial N.E.C; date published is 08/21/2020; address is 96 Jinsangmiro1385beon-gil , Icheon, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Daraeworld 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
- 96 Jinsangmiro1385beon-gil , Icheon, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 08/21/2020 verified
- Product code
- 62 H - - 99 Anti-Microbial N.E.C. verified
- Product
- Jeopureun Chowon Wiae Hand Sanitizer verified
- FDA notes
- The product appears to be an unapproved new drug as the product appears to be a topical antimicrobial drug product for over-the-counter human use that contains an active ingredient, tea tree oil, that 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
Daraeworld Co., Ltd. Date Published : 08/21/2020 96 Jinsangmiro1385beon-gil , Icheon, Gyeonggi KOREA (THE REPUBLIC OF) 62 H - - 99 Anti-Microbial N.E.C. Date Published: 08/21/2020 Desc: Jeopureun Chowon Wiae Hand Sanitizer Notes: The product appears to be an unapproved new drug as the product appears to be a topical antimicrobial drug product for over-the-counter human use that contains an active ingredient, tea tree oil, that 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
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