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Acne Cream - Drug or Cosmetic ?

Most foreign manufacturers of acne product are often asked for the US FDA requirements for acne cream / products to market in the USA. Acne products are considered as a cosmetic in most countries but it is regulated by FDA as a drug in the USA. The most common active ingredients used in the acne treatment products are Salicylic Acid and Benzoyl Peroxide, other active ingredients in OTC Monograph are Resorcinol, Resorcinol Monoacetate and Sulfur.

The FDA requirements for Acne cream or product are

For more information about FDA Acne products registration and listing or to register and list your acne product with US FDA please contact us at

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