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ACZONE (DAPSONE): PRESCRIBING INFORMATION
Aczone gel 5% contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Aczone (Dapsone) 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.
Each gram of Aczone gel contains 50 mg of dapsone, USP, in a gel of carbomer 980; diethylene glycol monoethyl ether, NF; methylparaben, NF; sodium hydroxide, NF; and purified water, USP.
INDICATIONS AND USAGE
Aczone (Dapsone) gel 5% is indicated for the topical treatment of acne vulgaris.
DOSAGE AND ADMINISTRATION
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 in a thin layer to the acne affected areas twice daily. Rub in Aczone (Dapsone) gently and completely. This medication 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 Dapsone (Aczone) should be reassessed.
DOSAGE FORMS AND STRENGTHS
Dapsone gel (Aczone) is supplied in the following size tubes:
Professional Sample: 3 gram laminate tube
Commercially: 30 and 60 gram laminate tubes
WARNINGS AND PRECAUTIONS
Aczone warnings and precautions
Aczone adverse reactions
Aczone drug interactions
USE IN SPECIFIC POPULATIONS
Aczone use in specific populations
Aczone (Dapsone) gel is not for oral use. If oral ingestion occurs, medical advice should be sought.
Aczone clinical pharmacology
Aczone nonclinical toxicology
Aczone clinical studies
HOW SUPPLIED / STORAGE AND HANDLING
Aczone (Dapsone) gel 5% is supplied in the following size tubes:
Professional Sample 5%, 3 gram laminate tube
Commercially Available as:
1) 5% 30 gram laminate tube
2) 5% 60 gram laminate tube
Keep out of the reach of children less than 12 years old.
Store at controlled room temperature, 20-25°C (68-76°F), excursions permitted to 15-30°C (59-86°F). Protect from freezing.
PATIENT COUNSELING INFORMATION
Information for patients
1. Patients should use Dapsone (Aczone) gel 5% as directed by the physician. This medication is for external topical use only. Dapsone (Aczone) gel is not for oral, ophthalmic or intravaginal use.
2. Patients should not use this medication for any disorder other than that for which it was prescribed.
3. Patients should report any signs of adverse reactions to their doctor, pharmacist, or other healthcare professional.
4. Protect Aczone gel from freezing.
5. See Patient Labeling for additional information on safety, efficacy, general use, and storage of Aczone gel 5%
Manufactured and distributed by Allergan, Tolmar pharmaceutical companies and its divisions.
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