FDA Approves First OTC Retinoid-Based Acne Treatment

The FDA has approved Differin Gel 0.1% for OTC use.

The product, which was originally approved in 1996 for prescription use, is indicated for the treatment of acne, is approved for use in individuals 12 years and older. It is the first retinoid-based acne treatment to be made available OTC.

“Millions of consumers, from adolescents to adults, suffer from acne,” said Lesley Furlong, MD, deputy director of the Office of New Drugs IV in the FDA’s Center for Drug Evaluation and Research. “Now, consumers have access to a new safe and effective over-the-counter option.”

The product’s safety and efficacy have been established in 5 clinical trials involving individuals with mild-to-moderate acne. The FDA based its approval on data gathered between 1996 and 2016 on postmarketing safety, as well as consumer studies.

Differin should not to be used on damaged skin, such as cuts, burns, or sunburns. Individuals may experience redness, itching, dryness, and burning sensations on their skin when using Differin for the first time. In the event that there is no improvement in acne after three months, individuals should consult their doctor. Pregnant women or those looking to become pregnant should also discuss the risks with their physician.

According to the American Academy of Dermatology, acne affects 50 million individuals in the United States. It is most common among teenagers and young adults, and pimples generally appear on the face, neck, back, chest, and shoulders.