FORT WORTH, Texas — Galderma Laboratories L.P. has gained Food and Drug Administration approval for Differin Gel, an over-the-counter treatment for acne.

Galderma said Friday that Differin Gel (adapalene gel 0.1%) is the first and only OTC acne product with a full prescription-strength retinoid, and the product represents the first new, FDA-approved active ingredient to be introduced to the OTC acne category in more than 30 years.

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

Applied once daily directly to the full face or other affected areas, Differin Gel is approved for use by people 12 years and older with acne. The clear gel has no fragrance, oil or alcohol, Galderma noted.

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

The dermatologist-developed and tested Differin Gel contains adapalene, a safe and effective retinoid, which is clinically proven to treat current and future breakouts and has been prescribed by doctors to over 40 million people globally for more than 20 years, according to Galderma. The company reported that American Academy of Dermatology therapeutic treatment guidelines recommend topical retinoids as a first-line therapy for all acne cases.

With a rising trend among consumers to self-treat, many people with acne are turning to the skin care aisle at their local drug store, Galderma said. The company noted that until now only two active ingredients have been available OTC and, consequently, many people have been dissatisfied with treatment results and searched for better options.

Galderma said the Rx to OTC switch of Differin Gel gives millions of people easier access to a prescription-strength acne treatment containing a retinoid.

“This landmark approval was years in the making at Galderma and demonstrates our ongoing commitment to individuals with dermatologic concerns such as acne,” stated Philip Brown, senior vice president of medical and regulatory Affairs at Galderma Labs. “Galderma will continue to partner with health care professionals and invest in Rx, OTC and aesthetic and corrective medical innovations to enhance skin health.”