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Benzoyl Peroxide is GRASE for OTC Acne Products

03/04/2010

Federal Register Final rule: FDA is issuing a final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in OTC topical acne drug products. It includes new warnings and directions required for such products. FDA is also revising labeling for OTC topical acne drug products containing resorcinol, resorcinol monoacetate, salicylic acid and/or sulfur to meet OTC drug labeling content and format requirements in a certain agency regulation. To view this final rule, click here.

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