"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
DOSAGE AND ADMINISTRATION
For topical use only; EPIDUO gel is not for oral, ophthalmic, or intravaginal use. Apply a thin film of EPIDUO 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.
Dosage Forms And Strengths
Each gram of EPIDUO gel contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide in a white to very pale yellow, opaque, aqueous based gel.
EPIDUO (adapalene and benzoyl peroxide) gel 0.1% / 2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows:
45 gram tube NDC 0299-5908-45
45 gram pump NDC 0299-5908-25
Storage and handling
- Store at 25°C; excursions permitted to 15° – 30° (59° – 86°F).
- Protect from light.
- Keep out of reach of children.
- Keep away from heat.
- Keep tube tightly closed.
Revised: January 2013. Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Manufactured by: Galderma Production Canada Inc., Baie d'Urfé, QC, H9X 3S4 Canada Made in Canada.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/26/2013
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