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Tag Archives: drug-products
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. We are 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 FDA regulation.
Posted in Acne News Also tagged are-issuing, conclusions, content-and, drug-labeling, include-benzoyl, rule-includes, salicylic-acid Leave a comment
Benzoyl Peroxide is now classified as safe by FDA