The Food and Drug Administration (FDA) is the regulatory agency that oversees the marketing of non-prescription acne products. In the Final Acne Monograph, an “acne drug product” is defined as: “A drug product used to reduce the number of acne blemishes, acne pimples, blackheads and whiteheads” (10).
The following ingredients and concentrations are currently allowed in OTC acne products.
• Salicylic acid 0.5-2%
• Sulfur 3-10% alone, or 3-8% in combination with resorcinol
• Resorcinol 2% or resorcinol monoacetate 3% in combination with sulfur 3-8%
• Benzoyl peroxide 2.5-10%
Salicylic acid, sulfur alone, or sulfur in combination with resorcinol are included in the Final Monograph for meeting the monograph conditions of being “generally recognized as safe and effective and not misbranded (Category I)” for the treatment of acne. Although the final rule on benzoyl peroxide is still pending, FDA has allowed its continued use in OTC acne products (11).
In the Final Acne Monograph, it also lays down the requirements for the labeling of OTC acne products. The labeling requirements include a statement of identity that contains the established name of the drug and identifies the product as an acne medication or treatment and the dosage form, a statement for the indications that the drug product is intended to treat; additional statements of treatment benefits; appropriate warnings; and directions of product usage. In the absence of a final ruling on the use of benzoyl peroxide in OTC acne products, manufacturers are referred to the proposed rules (12,13).