ACZONE (dapsone) Gel, 5%, is supplied in the following size tubes:
30 gram laminate tube
60 gram laminate tube
90 gram laminate tube
Store ACZONE gel at controlled room temperature, 20°-25°C (68°-77°F), excursions permitted to 15°-30ºC (59°-86ºF). Protect from freezing.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
- Inform patients that methemoglobinemia can occur with topical dapsone treatment. Advise patients to seek immediate medical attention if they develop cyanosis [see Warnings and Precautions ( 5.1)].
- Inform patients who have G6PD deficiency that hemolytic anemia may occur with topical dapsone treatment. Advise patients to seek medical attention if they develop signs and symptoms suggestive of hemolytic anemia [see Warnings and Precautions ( 5.2)].
Important Administration Instructions
- Advise patients to apply ACZONE Gel, 5%, twice daily to the acne affected area [see Dosage and Administration (2)].
- ACZONE Gel, 5% is for topical use only.
- Do not apply ACZONE Gel, 5% to eyes, mouth, or mucous membranes.
Distributed by: Allergan USA, Inc.
Madison, NJ 07940
© 2018 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
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|PATIENT INFORMATION ACZONE ® ( AK-zōn ) (dapsone) Gel, 5%|
|Important: For use on skin only (topical use). Do not use ACZONE® Gel, 5% in or on your mouth, eyes, or vagina.|
|What is ACZONE ® Gel , 5% ? ACZONE® Gel, 5% is a prescription medicine used on your skin (topical) to treat acne vulgaris.ACZONE® Gel has not been studied in children under 12 years of age.|
|Before using ACZONE ® Gel, 5%, tell your doctor about all of your medical conditions, including if you: |
|How should I use ACZONE ® Gel , 5% ? |
|What are the possible side effects of ACZONE ® Gel , 5% ? ACZONE ® Gel , 5% may cause serious side effects, including: |
|○ back pain||○ shortness of breath||○ tiredness or weakness|
|○ dark brown urine||○ fever||○ yellow or pale skin|
|The most common side effects of ACZONE® Gel, 5% include oiliness, peeling, dryness, and redness of the skin being treated.These are not all of the possible side effects of ACZONE® Gel, 5%. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store ACZONE ® Gel , 5% ? |
|General information about the safe and effective use of ACZONE ® Gel , 5% ? Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ACZONE® Gel, 5% for a condition for which it was not prescribed. Do not give ACZONE® Gel, 5% to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about ACZONE® Gel, 5% that is written for health professionals.|
|What are the ingredients in ACZONE ® Gel , 5% ? Active ingredient: dapsoneInactive ingredients: carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide, and purified water, USP.Distributed by: Allergan USA, Inc.Madison, NJ 07940© 2018 Allergan. All rights reserved. All trademarks are the property of their respective owners. v1.0PPI3670For more information, call 1-800-678-1605|
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 05/2018
PRINCIPAL DISPLAY PANEL
90 gRx Only
|ACZONE dapsone gel|
|Labeler — Allergan, Inc. (144796497)|
Revised: 05/2018 Allergan, Inc.
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