Daraeworld Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)
For Daraeworld 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 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 2026-10-01.
- 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)
— 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
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.
— 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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