Classification of benzoyl peroxide as safe and effective and revision of labeling to drug facts format; topical acne drug products for over-the-counter human use; final rule

Fed Regist. 2010 Mar 4;75(42):9767-77.

Abstract

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.

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Administration, Topical
  • Animals
  • Benzoyl Peroxide / adverse effects
  • Benzoyl Peroxide / classification*
  • Benzoyl Peroxide / radiation effects
  • Benzoyl Peroxide / therapeutic use
  • Carcinogenicity Tests
  • Carcinogens
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / classification*
  • Dermatologic Agents / radiation effects
  • Dermatologic Agents / therapeutic use
  • Drug Labeling / legislation & jurisprudence*
  • Humans
  • Mice
  • Mutagenicity Tests
  • Mutagens
  • Nonprescription Drugs / adverse effects
  • Nonprescription Drugs / classification
  • Nonprescription Drugs / radiation effects
  • Nonprescription Drugs / therapeutic use
  • Resorcinols / adverse effects
  • Resorcinols / classification*
  • Resorcinols / therapeutic use
  • Salicylic Acid / adverse effects
  • Salicylic Acid / classification*
  • Salicylic Acid / therapeutic use
  • Sulfur / adverse effects
  • Sulfur / classification*
  • Sulfur / therapeutic use
  • Ultraviolet Rays / adverse effects
  • United States

Substances

  • Carcinogens
  • Dermatologic Agents
  • Mutagens
  • Nonprescription Drugs
  • Resorcinols
  • Sulfur
  • Salicylic Acid
  • Benzoyl Peroxide
  • resorcinol monoacetate