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FDA OTC Drug Establishment Registration

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Published date: April 25, 2025
  • Location: Colorado City, Colorado, United States
FDA OTC Drug Establishment Registration
FDA OTC Drug Establishment Registration
If your Canadian, French or Italian company's products are any of the following, then an OTC Drug Establishment Registration is required, and not MoCRA Registration:

Antidandruff shampoo
Toothpaste containing fluoride
Deodorant that is also antiperspirant
Moisturizer and makeup marketed with sun-protection claims
Sunscreens.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.fda.itbhdg.com/product/otc-cosmetics/

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