Adapalene Gel
Product Images NDC 72657-158

This is a Drug Facts label for Adapalene Gel USP, 0.1%, an over-the-counter acne treatment product. It contains warnings and directions for use, including a caution not to use the product on damaged skin or if the user is allergic to adapalene or any of its inactive ingredients. It also warns against waxing after application of the product and advises users that their acne may initially worsen before improving. In case of irritation, the user should discontinue use or seek medical attention if it becomes severe. The label includes important information about potential allergic reactions, and it cautions users to avoid contact with eyes, lips, and mouth. The product is distributed by Galderma Laboratories, L.P. and is a registered trademark of Differin. The label also gives a website and phone number for questions or comments.*

This is the description of an FDA-approved over-the-counter acne treatment that contains Adapalene gel USP 0.1%, a retinoid. The product comes with a consumer information leaflet, which should be read before use. It is oil-free, fragrance-free, and dermatologist-developed and tested. This medication treats acne and should be used only externally. It should not be applied to damaged skin, and people allergic to Adapalene or its ingredients should avoid using it. Women who are pregnant or breastfeeding should ask a doctor before use. Sun exposure should be limited during treatment and sunscreen should be used when going outdoors. Avoid using other topical acne medications simultaneously. Irritation may occur, particularly during the first few weeks of use, and it may take up to three months of once-daily use to see results. Keep the product out of reach from children and store at room temperature. The inactive ingredients include carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. The product is distributed by Glenmark Therapeutics Inc., USA.*