O'will Corporation · 66-41 · JAPAN
For O'will Corporation, import alert is 66-41; country is JAPAN; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product code is 53 - - - -- Cosmetics | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 09/30/2009; address is 2 Chome 13-12 , Hirakawa-Cho , Chiyoda, Tokyo JAPAN, verified against its source on 2026-10-01.
- Firm
- O'will Corporation verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- JAPAN verified
- Address
- 2 Chome 13-12 , Hirakawa-Cho , Chiyoda, Tokyo JAPAN verified
- Date published
- 09/30/2009 verified
- Product code
- 53 - - - -- Cosmetics | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- FDA notes
- 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications. | 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications. each item verified
What the source says
O'will Corporation Date Published : 09/30/2009 2 Chome 13-12 , Hirakawa-Cho , Chiyoda, Tokyo JAPAN
— 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 and FDA notes
53 - - - -- Cosmetics Date Published: 09/30/2009 Notes: 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/30/2009 Notes: 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications.
— 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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