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Yes. In the United States, azelaic acid 15% is prescription-only when sold as a medicated treatment. FDA-approved azelaic acid 15% products, such as Finacea Gel 15% and Finacea Foam 15%, are prescription topical medications used for inflammatory papules and pustules of mild to moderate rosacea. DailyMed lists Finacea Gel 15% packaging as “Rx only.” The FDA labeling also identifies Finacea Gel as azelaic acid gel, 15% for topical use and indicated for mild to moderate rosacea.
Some lower-strength azelaic acid skincare products may be sold over the counter, but 15% azelaic acid drug products in the U.S. require a prescription.
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