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Galderma Receives U.S. FDA Approval for Differin Epiduo Acne Gel

Galderma
Galderma

On May 22, 2026, pure-play dermatology category leader, Galderma, announced its Differin Epiduo Acne Gel was approved by the United States Food and Drug Administration (FDA) for over-the-counter use in ages 12 years and older. 

Most OTC acne products only contain benzoyl peroxide or salicylic acid, making Galderma's prescription-strength treatment — which combines adapalene 0.1% (a retinoid) with benzoyl peroxide 2.5% in a single formulation — accessible without a physician's visit.

Related: 5 Notable Developments in Derm-Recommended OTC Skin Care [Survey Results]

While medical-grade, professional skin care is the best option when it comes to recommending clinical topical solutions for patients' skin concerns, dermatologist-recommended over-the-counter skin care brands like Galderma offers patients a take-home acne care option that's been backed by more than 15 years of real-world dermatologist use and a robust clinical research program. 

Med spa and wellness facilities can now enhance their patient care by providing the best treatment available for each patient, as patients are always looking for dermatologist recommended OTC skin care brands. Similarly, practitioners can now add Galderma's Differin Epiduo Acne Gel to their list of dermatologist-trusted, prescription-strength treatments when planning a skin care regimen to treat acne. 

Related: How to Subdue Stubborn Acne for Good

"The approval of Differin Epiduo over the counter allows for more open access to a clinically proven acne treatment for those who are not currently under a dermatologist’s care and are not experiencing severe acne," Dr. Bill Andriopoulos, who is Head of Global Medical Affairs at Galderma, says to MedEsthetics.

"This approval also gives dermatologists an OTC option with robust clinical evidence for their patients. Importantly, dermatologists remain the most trusted source for guidance on acne management, particularly when OTC care is not sufficient. If acne does not improve with consistent OTC treatment or is severe, painful, or scarring, consulting a dermatologist is always recommended," Dr. Andriopoulos continues. 

The Prescription‑to‑OTC transition highlights Galderma’s scale and expertise in successfully commercializing dermatology innovations across the full spectrum of acne care, which is especially important during a time where acne treatment is needed. 

"Acne is affecting a growing proportion of the population, with almost half of people ages 18-34 experiencing acne. At the same time, more acne sufferers are self-managing care, with non-prescription product use rising. This created a clear need for more effective, clinically proven options in the OTC space, which Differin Epiduo is uniquely positioned to address,"Andriopoulos says. 

The topical acne treatment is able to clear clogged pores, kill acne-causing bacteria, reducing acne inflammation and prevent future breakouts, all due to the combination of its two main components: Adapalene and benzoyl peroxide — together, these two dermatologist-trusted ingredients address key biological drivers of acne. 

Differin Epiduo will be available over-the-counter at most major retailers, including Walmart, Ulta, Target and Amazon, beginning in the summer of 2026. With a commitment to providing effective solutions across consumers’ acne journey, the Differin portfolio also includes cleansers, treatments, and moisturizers to support and provide wholistic solutions. For more information on Differin Epiduo and other Differin products, please visit www.differin.com

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