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

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: 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:** 96 Jinsangmiro1385beon-gil , Icheon, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 08/21/2020 _(verified: appears in the quote below)_
- **Product code:** 62 H - - 99 Anti-Microbial N.E.C. _(verified: appears in the quote below)_
- **Product:** Jeopureun Chowon Wiae Hand Sanitizer _(verified: appears in the quote below)_
- **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: appears in the quote below)_

## 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.

## 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/).