"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.
Atralin Gel is indicated for topical treatment of acne vulgaris.
DOSAGE AND ADMINISTRATION
For topical use only. Not for ophthalmic, oral, or intravaginal use.
Atralin Gel should be applied once daily, before bedtime, to the skin where acne lesions appear, using a thin layer to cover the entire affected area. Atralin Gel should be kept away from the eyes, the mouth, paranasal creases, and mucous membranes. Application of excessive amounts of gel will not provide incremental efficacy.
Patients treated with Atralin Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.
When treating with Atralin Gel, caution should be exercised with the use of concomitant topical over-the-counter preparations, topical medications, medicated or abrasive soaps and cleansers, products that have strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel has begun.
Dosage Forms And Strengths
Each gram of Atralin Gel contains 0.5 mg (0.05%) tretinoin in a translucent to opaque, pale yellow topical gel.
Atralin (tretinoin) Gel, 0.05% is a translucent to opaque, pale yellow topical gel and available as:
45 g tubes (NDC 13548-070-45)
Storage And Handling
Store at controlled room temperature 20° - 25°C (68° - 77°F) with excursions permitted between 15°-30°C (59°-86°F). Protect from freezing. Keep out of reach of children.
Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 by: DPT Laboratories, Ltd., San Antonio, TX 78215. Revised: 08/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/10/2014
Additional Atralin Information
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