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ACZONE- dapsone gel


  1. Before You Use Aczone Gel, 7.5%, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  2. How Do I Use Aczone Gel, 7.5%?
  3. Aczone Gel, 7.5% May Cause Serious Side Effects, Including:
  4. How Should I Store Aczone Gel, 7.5%?
  5. Active Ingredient:
  6. Inactive Ingredients:
  7. Patient Information

Before You Use Aczone Gel, 7.5%, Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

  • have a glucose-6-phosphate dehydrogenase deficiency (G6PD)
  • have higher than normal levels of methemoglobin in your blood (methemoglobinemia)
  • are pregnant or plan to become pregnant. It is not known if ACZONE Gel, 7.5% will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. ACZONE Gel, 7.5% can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use ACZONE Gel, 7.5%, or breastfeed. You should not do both.

Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially, tell your doctor if you are using acne medicines that contain benzoyl peroxide. Use of benzoyl peroxide with ACZONE Gel, 7.5% at the same time may cause your skin or facial hair to temporarily turn yellow or orange at the site of application.

How Do I Use Aczone Gel, 7.5%? 

  • Use ACZONE Gel, 7.5% exactly as your doctor tells you to use it.
  • Apply ACZONE Gel, 7.5% one time a day.
  • Gently wash and pat dry the areas of your skin where you will apply ACZONE Gel, 7.5%.
  • Apply a pea-sized amount of ACZONE Gel, 7.5% in a thin layer to the entire face. A thin layer may also be applied to other affected areas as instructed by your doctor.
  • Rub ACZONE Gel, 7.5% in gently and completely.
  • Wash your hands after applying ACZONE Gel, 7.5%.
  • If your acne does not get better after using ACZONE Gel, 7.5% for 12 weeks, talk to your doctor about continuing treatment.

Aczone Gel, 7.5% May Cause Serious Side Effects, Including: 

  • Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia).Stop using ACZONE Gel, 7.5% and get medical help right away if your lips, nail beds, or the inside of your mouth turns grey or blue.
  • Breakdown of red blood cells (hemolytic anemia).Some people with G6PD deficiency using ACZONE Gel, 7.5% may develop mild hemolytic anemia. Stop using ACZONE Gel, 7.5% and tell your doctor right away if you get any of the following signs and symptoms:
    • back pain
    • dark brown urine
    • shortness of breath
    • fever
    • tiredness or weakness
    • yellow or pale skin

The most common side effects of ACZONE Gel, 7.5% include dryness and itching of the skin being treated. These are not all of the possible side effects of ACZONE Gel, 7.5%. 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, 7.5%? 

  • Store ACZONE Gel, 7.5%, at room temperature 68 F to 77 F (20 C to 25 C).
  • Protect ACZONE Gel, 7.5% from freezing.

Keep ACZONE Gel, 7.5% and all medicines out of the reach of children.

General information about the safe and effective use of ACZONE Gel, 7.5%.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ACZONE Gel, 7.5% for a condition for which it was not prescribed. Do not give ACZONE Gel, 7.5% to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about ACZONE Gel, 7.5% that is written for health professionals.

Active Ingredient: 

dapsone

Inactive Ingredients: 

diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water.


Distributed by: Almirall, LLC

Exton, PA 19341


2019 Almirall, LLC. All rights reserved.

All trademarks are the property of their respective owners.

Patented.


For more information, call 1-866-665-2782


Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hematological Effects

  • 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 applyACZONEGel, 5%, twice daily to the acne affected area [see Dosage and Administration (2)].
  • ACZONEGel, 5% is for topical use only.
  • Do not applyACZONEGel, 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.

Allergan

v1.0USPI3670

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