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Dapsone Topical (Aczone): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Being discontinued since March 27, 2026
Strength:
75 mg/g
Brand names:
Drug class:
Active ingredient:

Patient information: uses, side effects, how to take - Dapsone Topical

What is dapsone gel, 7.5%?

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

Dapsone gel, 7.5%, has not been studied in children under 9 years of age.

Before you use dapsone 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 dapsone gel, 7.5% will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. Dapsone gel, 7.5% can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use dapsone 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 dapsone 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 dapsone gel, 7.5%?

  • Use dapsone gel, 7.5% exactly as your doctor tells you to use it.
  • Apply dapsone gel, 7.5% one time a day.
  • Gently wash and pat dry the areas of your skin where you will apply dapsone gel, 7.5%.
  • Apply a pea-sized amount of dapsone 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 dapsone gel, 7.5% in gently and completely.
  • Wash your hands after applying dapsone gel, 7.5%.
  • If your acne does not get better after using dapsone gel, 7.5% for 12 weeks, talk to your doctor about continuing treatment.

What are the possible side effects of dapsone gel, 7.5%?

Dapsone 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 dapsone 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 dapsone gel, 7.5% may develop mild hemolytic anemia. Stop using dapsone 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 dapsone gel, 7.5% include dryness and itching of the skin being treated. These are not all of the possible side effects of dapsone 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 dapsone gel, 7.5%?

  • Store dapsone gel, 7.5% at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15 ºC to 30 ºC (59 ºF to 86 ºF). [see USP Controlled Room Temperature].
  • Protect dapsone gel, 7.5% from freezing.

Keep dapsone gel, 7.5% and all medicines out of the reach of children.

General information about the safe and effective use of dapsone gel, 7.5%.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use dapsone gel, 7.5% for a condition for which it was not prescribed. Do not give dapsone 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 dapsone gel, 7.5% that is written for health professionals.

For more information call Torrent Pharma Inc. at 1-800-912-9561.

What are the ingredients in dapsone gel, 7.5%?

Active ingredient: dapsone, USP

Inactive ingredients: carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water.

Manufactured by:

Encube Ethicals Pvt. Ltd.

Madkaim, Ponda, Goa – 403404 India

Manufactured for:

TORRENT PHARMA INC. Basking Ridge, NJ 07920

8101158 Revised: June 2025

This Patient Information has been approved by the U.S. Food and Drug Administration.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 214722 · View the label on DailyMed

Revision date stated in the text: June 2025

Found a mistake? Write to us via the contact page.

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

Drug information for Dapsone Topical

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) TORRENT
FDA approval ANDA 214722Abbreviated New Drug Application (ANDA) – generic drug Approved February 10, 2022
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Aczone with the same TE code
Manufacturers 18 labelers list this drug on DailyMed
Drug shortage
  • Being discontinued since March 27, 2026
Recalls
  • December 10, 2024: Class II recall: Crystallization
  • December 10, 2024: Class II recall: Crystallization
  • October 29, 2024: Class II recall: Crystallization
Packages (NDC)
Package
75 mg/g – 60 g in 1 bottle, pump / 1 in 1 carton NDC 13668-605-05
75 mg/g – 90 g in 1 bottle, pump / 1 in 1 carton NDC 13668-605-08

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.