Acne Products
Over-the-counter (OTC) acne products are regulated by the FDA through a monograph system. This means there are specific rules manufacturers must follow to ensure their products are safe and effective. These rules cover things like the types and concentrations of ingredients allowed in the product, as well as the labeling. There are five ingredients currently approved for OTC acne treatment: benzoyl peroxide, salicylic acid, sulfur, and combinations of resorcinol or resorcinol monoacetate with sulfur. These ingredients work in various ways to combat acne such as reducing the number of acne pimples, blackheads or whiteheads and and allows skin to heal.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Benzoyl peroxide, 2.5 to 10 percent | M006.10 (Part 333) |
| Resorcinol, 2 percent, when combined with sulfur | M006.10 (Part 333) |
| Resorcinol monoacetate, 3 percent, when combined with sulfur | M006.10 (Part 333) |
| Salicylic acid, 0.5 to 2 percent | M006.10 (Part 333) |
| Sulfur, 3 to 10 percent | M006.10 (Part 333) |
| Sulfur, 3 to 8 percent when combined with resorcinol or resorcinol monoacetate | M006.10 (Part 333) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
The FDA requirements for Acne cream
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