Source: FDA, National Drug Code (US) Revision Year: 2019
ACZONE (dapsone) Gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. ACZONE Gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white or slightly yellow-white, crystalline powder that has a molecular weight of 248.30. Dapsone’s chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its structural formula is:
Each gram of ACZONE Gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water.
| Dosage Forms and Strengths |
|---|
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Gel, 7.5%. Each gram of ACZONE Gel, 7.5% contains 75 mg of dapsone in an off-white to yellow gel with suspended particles. |
| How Supplied |
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ACZONE Gel is an off-white to yellow gel with suspended particles. It is supplied in an airless pump containing a polypropylene bottle with a high density polyethylene piston. ACZONE (dapsone) Gel, 7.5%, is supplied in the following sizes: NDC 16110-526-30 30 gram pump Distributed by: Almirall, LLC., Exton, PA 19341 |
| Drug | Countries | |
|---|---|---|
| ACZONE | Canada, New Zealand, United States |
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