FDA Registration OTC Drug Establishment
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- Hi annatrade,
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/
▪ 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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