FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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Legal Issues
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FDA Labeling Changes
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Uses
ACZONE® Gel, 5%, is indicated for the topical treatment of acne vulgaris.
History
There is currently no drug history available for this drug.
Other Information
ACZONE® Gel, 5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. ACZONE® Gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white, odorless crystalline powder that has a molecular weight of 248. Dapsone's chemical name is 4,4'-diaminodiphenylsulfone and its structural formula is:
Each gram of ACZONE® Gel, 5%, contains 50 mg of dapsone, USP, in a gel of carbomer homopolymer type C; diethylene glycol monoethyl ether, NF; methylparaben, NF; sodium hydroxide, NF; and purified water, USP.
Sources
Aczone Manufacturers
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Allergan, Inc.
Aczone | Allergan, Inc.
For topical use only. Not for oral, ophthalmic, or intravaginal use.
After the skin is gently washed and patted dry, apply approximately a pea-sized amount of ACZONE® Gel, 5%, in a thin layer to the acne affected areas twice daily. Rub in ACZONE® Gel, 5%, gently and completely. ACZONE® Gel, 5%, is gritty with visible drug substance particles. Wash hands after application of ACZONE® Gel, 5%.
If there is no improvement after 12 weeks, treatment with ACZONE® Gel, 5%, should be reassessed.
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