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DAPSONE gel


  1. Before Using Dapsone Gel, 5%, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  2. How Should I Use Dapsone Gel, 5%?
  3. Dapsone Gel, 5% May Cause Serious Side Effects, Including:
  4. How Should I Store Dapsone Gel, 5%?
  5. General Information About The Safe And Effective Use Of Dapsone Gel, 5%?
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. Patient Information

Before Using Dapsone Gel, 5%, Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

  • Have 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 Dapsone Gel, 5 % will harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. Dapsone Gel, 5% can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use Dapsone Gel, 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 Dapsone Gel, 5% at the same time may cause your skin or facial hair to temporarily turn yellow or orange at the site of application.

How Should I Use Dapsone Gel, 5%? 

  • Use Dapsone Gel, 5% exactly as your doctor tells you.
  • Apply Dapsone Gel, 5% twice a day.
  • Gently wash and pat dry the areas of your skin where you will apply Dapsone Gel, 5%.
  • Apply a pea-sized amount of Dapsone Gel, 5% in a thin layer to the areas of your skin that have acne.
  • Rub Dapsone Gel, 5% in gently and completely. It may feel gritty and you may

Dapsone Gel, 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 Dapsone Gel, 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 Dapsone Gel, 5% have developed mild hemolytic anemia. Stop using Dapsone Gel, 5% and tell your doctor right away if you get any of the following signs and symptoms:
    • back pain
    • shortness of breath
    • tiredness or weakness
    • dark brown urine
    • fever
    • yellow or pale skin
The most common side effects of Dapsone Gel, 5% include oiliness, peeling, dryness, and redness of the skin being treated.These are not all of the possible side effects of Dapsone 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 Dapsone Gel, 5%? 

  • Store Dapsone Gel, 5% at room temperature, 68 to 77 F (20 to 25 C).
  • Protect Dapsone Gel, 5% from freezing.
Keep Dapsone Gel, 5% and all medicines out of the reach of children.

General Information About The Safe And Effective Use Of Dapsone Gel, 5%? 

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Dapsone Gel, 5% for a condition for which it was not prescribed. Do not give Dapsone 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 Dapsone Gel, 5% that is written for health professionals.

Active Ingredient: 

dapsone, USP

Inactive Ingredients: 

carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, purified water and sodium hydroxideManufactured by: Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532For more information, call 1-866-923-4914

This Patient Information has been approved by the U.S. Food and Drug Administration.
LPK-8223-2 52
Revised: June, 2018

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[seeWarnings 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 dapsone gel, 5%, twice daily to the acne affected area[see Dosage and Administration (2)].
  • Dapsone gel, 5%, is for topical use only.
  • Do not apply dapsone gel, 5%to eyes, mouth, or mucous membranes.

Distributed for Allergan USA, Inc.

Madison, NJ 07940

2018 Allergan. All rights reserved.

All trademarks are the property of their respective owners.

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