FDA Registration OTC Drug Establihment
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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/
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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