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Aczone (Dapsone): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
75 mg/g
Drug class:
Active ingredient:

Patient information: uses, side effects, how to take - Aczone

What is ACZONE Gel, 7.5%?

ACZONE Gel, 7.5%, is a prescription medicine used on the skin (topical) to treat acne in people 9 years and older.

ACZONE Gel, 7.5%, has not been studied in children under 9 years of age.

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.

What are the possible side effects of ACZONE Gel, 7.5%?

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.

What are the ingredients in ACZONE Gel, 7.5%?

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

Malvern, PA 19355

Aczone® is a registered trademark of Almirall, LLC

© 2019 Almirall, LLC. All rights reserved.

Patented.

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

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 207154 · View the label on DailyMed

Revision date stated in the text: December 2021

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Aczone

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Sulfone
Active ingredient Dapsone 75 mg/g
Dosage form Gel
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) ALMIRALL
FDA approval NDA 207154New Drug Application (NDA) Approved February 24, 2016
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Dapsone Topical with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
75 mg/g – 30 g in 1 bottle, pump / 1 in 1 carton NDC 16110-526-30
75 mg/g – 60 g in 1 bottle, pump / 1 in 1 carton NDC 16110-526-60
75 mg/g – 90 g in 1 bottle, pump / 1 in 1 carton NDC 16110-526-90

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.