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Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Apply a thin film of Adapalene & Benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adapalene & Benzoyl peroxide is not for oral, ophthalmic, or intravaginal use.
Erythema, scaling, dryness, and stinging/ burning may occur. Most commonly reported adverse events are dry skin, contact dermatitis, application site burning, application site irritation, and skin irritation.
Pregnancy & Lactation
There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl peroxide. Animal reproduction studies have not been conducted with the combination gel or Benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, this preparation should be used during pregnancy only if the potential benefit justifies the risk to the fetus. It is not known whether Adapalene or Benzoyl peroxide is excreted in human milk following use. Caution should be exercised when administered to a nursing woman.
Precautions & Warnings
Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.
Use in Special Populations
Safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 12 years have not been established.
Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.