Rx Item-Aczone 5% Gel 30gm By Allergan Pharma

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.

Rx Item-Aczone 5% Gel 30gm By Allergan P
NDC No.00023-3670-30 UPC/GTIN No.3-00233-67030-9 MPN No. 93670 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA,

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Allergan USA, Inc.

DAPSONE TOPICAL GEL (GRAM
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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