FDA Issues Guidance on Acne Product Labeling & Classification
The Food and Drug Administration is announcing the availability of a guidance for small business entities entitled “Topical Acne Drug Products for Over-the-Counter Human Use - Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective," which is…
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intended to help small businesses understand and comply with the requirements of the final rule that adds benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter topical acne drug products and provides new labeling requirements applicable to all OTC topical acne products marketed under the monograph.