Classification of benzoyl peroxide as safe and effective and revision of labeling to drug facts format; topical acne drug products for…

Authors: We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this final rule includes new warnings and directions required for OTC acne drug products containing benzoyl peroxide.

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Classification of benzoyl peroxide as safe and effective and revision of labeling to drug facts format; topical acne drug products for…

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