FDA Approves Differin Gel For OTC Acne Use

FDA Approves Differin Gel For OTC Acne Use

Galderma Laboratories has received approval from the U.S. Food and Drug Administration (FDA) for Differin Gel (adapalene gel 0.1%) as an over-the-counter (OTC) treatment for acne—the first and only OTC acne product containing a full prescription-strength retinoid. It also marks the first new, FDA-approved active ingredient to be introduced to the OTC acne category in more than three decades. Differin Gel is a once-daily topical indicated to treat current and future breakouts in people age 12 and older. The 0.1% adapalene gel is clear, fragrance-free, oil-free and alcohol-free.

“We believe bringing Differin Gel over-the-counter will be a game-changer for consumers and for the acne category,” said Miles Harrison, president and general manager of Galderma Laboratories. “We’re excited to deliver this new level of efficacy without a prescription to consumers, and to bring the first new active ingredient to the category in over 30 years.”

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