# Revivre Cosmetiques · 66-41 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For Revivre Cosmetiques · 66-41 · ITALY, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is ITALY; product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 64 X - - 07 Tretinoin (Keratolytic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 09/30/2009; address is Via Vallina Orticella 34 , Borso del Grappa, Treviso ITALY, verified against its source on 2026-09-16.

- **Firm:** Revivre Cosmetiques _(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:** ITALY _(verified: appears in the quote below)_
- **Address:** Via Vallina Orticella 34 , Borso del Grappa, Treviso ITALY _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 64 X - - 07 Tretinoin (Keratolytic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **FDA notes:** Dermopura Acneiche Treatment against acne and scarring. 12/3/1998 CDER has determined this product to be marketed over the internet and promoted for use as a treatment against "acne and scarring." The active ingrediants include "azelaic acid". That ingrediant offered as an OTC acne treatment, is a new drug, requiring an NDA to obtain marketing authorization and should not be promoted as an OTC product. This product also appears to be in violation of the final rule (21 CFR section 333.301) covering acne products. Questions regarding this product or other similar products should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division of Drug Labeling and Non- Prescription Drug Compliance, HFD-312, 301-594-1065. | Dermopura Acneiche Treatment against acne and scarring. 12/3/1998 CDER has determined this product to be marketed over the internet and promoted for use as a treatment against "acne and scarring." The active ingrediants include "azelaic acid". That ingrediant offered as an OTC acne treatment, is a new drug, requiring an NDA to obtain marketing authorization and should not be promoted as an OTC product. This product also appears to be in violation of the final rule (21 CFR section 333.301) covering acne products. Questions regarding this product or other similar products should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division of Drug Labeling and Non- Prescription Drug Compliance, HFD-312, 301-594-1065. | Dermopura Acneiche Treatment against acne and scarring. 12/3/1998 CDER has determined this product to be marketed over the internet and promoted for use as a treatment against "acne and scarring." The active ingrediants include "azelaic acid". That ingrediant offered as an OTC acne treatment, is a new drug, requiring an NDA to obtain marketing authorization and should not be promoted as an OTC product. This product also appears to be in violation of the final rule (21 CFR section 333.301) covering acne products. Questions regarding this product or other similar products should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division of Drug Labeling and Non- Prescription Drug Compliance, HFD-312, 301-594-1065. _(verified: each item appears in the quote below)_

## What the source says

> Revivre Cosmetiques Date Published : 09/30/2009 Via Vallina Orticella 34 , Borso del Grappa, Treviso ITALY 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 09/30/2009 Notes: Dermopura Acneiche Treatment against acne and scarring. 12/3/1998 CDER has determined this product to be marketed over the internet and promoted for use as a treatment against "acne and scarring." The active ingrediants include "azelaic acid". That ingrediant offered as an OTC acne treatment, is a new drug, requiring an NDA to obtain marketing authorization and should not be promoted as an OTC product. This product also appears to be in violation of the final rule (21 CFR section 333.301) covering acne products. Questions regarding this product or other similar products should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division of Drug Labeling and Non- Prescription Drug Compliance, HFD-312, 301-594-1065. 64 X - - 07 Tretinoin (Keratolytic) Date Published: 09/30/2009 Notes: Dermopura Acneiche Treatment against acne and scarring. 12/3/1998 CDER has determined this product to be marketed over the internet and promoted for use as a treatment against "acne and scarring." The active ingrediants include "azelaic acid". That ingrediant offered as an OTC acne treatment, is a new drug, requiring an NDA to obtain marketing authorization and should not be promoted as an OTC product. This product also appears to be in violation of the final rule (21 CFR section 333.301) covering acne products. Questions regarding this product or other similar products should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division of Drug Labeling and Non- Prescription Drug Compliance, HFD-312, 301-594-1065. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/30/2009 Notes: Dermopura Acneiche Treatment against acne and scarring. 12/3/1998 CDER has determined this product to be marketed over the internet and promoted for use as a treatment against "acne and scarring." The active ingrediants include "azelaic acid". That ingrediant offered as an OTC acne treatment, is a new drug, requiring an NDA to obtain marketing authorization and should not be promoted as an OTC product. This product also appears to be in violation of the final rule (21 CFR section 333.301) covering acne products. Questions regarding this product or other similar products should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division of Drug Labeling and Non- Prescription Drug Compliance, HFD-312, 301-594-1065.

## 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/).