FDA Registration OTC Drug Establihment
FDA Registration OTC Drug Establihment

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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