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Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format - Topical Acne Drug Products (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) The Law Library

Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format - Topical Acne Drug Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format - Topical Acne Drug Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 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. This final rule is part of our ongoing review of OTC drug products and represents our conclusions on benzoyl peroxide in OTC acne drug products. This book contains: - The complete text of the Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format - Topical Acne Drug Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section