Item info. These highlights do not include all the info. needed to use ACZONE Gel, 5% safely and effectiv ely. See full prescribing info. for ACZONE Gel, 5%. ACZONE (dapsone) Gel, 5%, for topical use only Initial U.S. Approval: 1955 -RECENT MAJOR CHANGES Warnings and Precautions, Methemoglobinemia 7/2015 INDICATIONS AND USAGE ACZONE Gel is indicated for the topical treatment of acne vulgaris . DOSAGE AND ADMINISTRATION - Apply twice daily . Apply approximately pea-sized amount of ACZONE Gel, 5%, in thin layer to the acn affected area . If there is no improvement after 12 weeks, treatment with ACZONE Gel, 5%, should be reassessed . For topical use only. Not for oral, ophthalmic, or intravaginal use . -DOSAGE FORMS AND STRENGTHS -- Gel, 5% . --CONTRAINDICATIONS None . --WARNINGS AND PRECAUTIONS Methemoglobinemia: Cases of methem oglobinemia have been reported. Discontinue ACZONE gel if signs of methemoglobinemia occur . Hematologic Effects: Some subjec ts with G6PD deficiency using ACZONE Gel developed laboratory changes suggestive of hemolysis. . -ADVERSE REACTIONS - Most common adverse reactions (incidence 10%) are oiliness/peeling, dryness and erythema at the application site . To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Trimethoprim/sulfamethoxazole (TMP/SMX) increases the level of dapsone and its metabolites . Topical benzoyl peroxide used at the same time as ACZONE may result in temporary local yellow or orange skin discoloration . See 17 for PATIENT COUNSELING info. and FDA- approved patient labeling.