Brand Name

Aczone

Generic Name
Dapsone
View Brand Information
FDA approval date: June 24, 2009
Classification: Sulfone
Form: Tablet, Gel

What is Aczone (Dapsone)?

For many people, acne is more than just a cosmetic issue, it can affect confidence, comfort, and quality of life. Persistent breakouts and skin inflammation can be frustrating, especially when over-the-counter products don’t seem to work. Aczone (dapsone) offers an effective, dermatologist-recommended solution for those struggling with acne that resists standard treatments. 

Aczone is a topical prescription medication belonging to a class of drugs known as sulfonamides, which have antibacterial and anti-inflammatory properties. It helps treat acne by targeting both the bacteria and inflammation that contribute to breakouts. Approved by the U.S. Food and Drug Administration (FDA), Aczone is commonly used as a maintenance or adjunct therapy for moderate acne. Available in gel form, it is typically well-tolerated and can fit easily into daily skincare routines, helping patients achieve clearer, healthier-looking skin over time. 

What does Aczone do? 

Aczone is primarily used to treat acne vulgaris, the most common type of acne affecting teens and adults. Acne develops when pores become clogged with oil, dead skin cells, and bacteria, leading to pimples, blackheads, or inflamed lesions. 

The active ingredient in Aczone, dapsone, helps reduce these symptoms by targeting both the bacterial and inflammatory aspects of acne. When applied regularly, Aczone can: 

  • Decrease the number and severity of acne lesions 
     
  • Reduce redness, swelling, and tenderness 
     
  • Help prevent new breakouts 

Clinical studies have shown that Aczone can significantly improve acne symptoms after consistent use, with noticeable results often seen within 8 to 12 weeks (NIH, 2024). For many patients, it becomes an essential part of a long-term acne management plan that supports clearer skin and improved confidence. 

While Aczone is mainly known for acne treatment, oral forms of dapsone are also used for other conditions such as dermatitis herpetiformis (a skin condition linked to celiac disease) and certain bacterial infections. However, when used topically as Aczone gel, the medication acts mainly on the skin and has fewer systemic effects. 

How does Aczone work? 

Aczone works through a dual mechanism, it reduces both inflammation and bacterial growth on the skin. 

Dapsone targets Propionibacterium acnes (now called Cutibacterium acnes), the bacteria that contribute to acne formation. By inhibiting bacterial enzyme activity, it helps control infection and prevents the buildup of pus and inflammation within clogged pores. 

At the same time, dapsone acts as an anti-inflammatory agent, calming the immune response that can cause redness, swelling, and irritation around pimples. This combination helps improve both inflammatory acne (such as red, swollen pimples) and non-inflammatory acne (such as whiteheads and blackheads). 

This mechanism matters clinically because acne is not caused by bacteria alone, inflammation plays an equally significant role. By addressing both causes simultaneously, Aczone helps promote smoother skin texture and a healthier complexion without the harshness often associated with stronger acne medications. 

Aczone side effects 

Aczone is generally well-tolerated when used as directed, but some people may experience mild or temporary side effects, particularly in the first few weeks of use. 

Common side effects may include: 

  • Dryness or peeling at the application site 
     
  • Mild redness or irritation 
     
  • Itching or burning sensation 
     
  • Oiliness in the skin after application 

These symptoms typically fade as the skin adjusts to the medication. Applying a gentle, non-comedogenic moisturizer can help minimize dryness or irritation. 

Less common but serious side effects may include: 

  • Yellowing of the skin or eyes (signs of liver issues or hemolysis) 
     
  • Dark brown or grayish skin discoloration (methemoglobinemia) 
     
  • Fatigue or shortness of breath (possible blood-related reaction) 

Serious side effects are rare, especially with topical use, but they are more likely in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, a genetic condition that affects red blood cell metabolism. For this reason, doctors may screen patients for G6PD deficiency before prescribing Aczone. 

Patients should seek immediate medical attention if they experience unusual tiredness, bluish lips or fingertips, shortness of breath, or severe skin discoloration, as these could signal a rare but serious reaction. 

Aczone dosage 

Aczone topical gel (5% or 7.5%) is applied once or twice daily to affected areas. Patients should cleanse and dry their face, then apply a thin layer to the entire affected area to prevent breakouts. 

Because dapsone is absorbed through the skin, healthcare providers may recommend periodic blood tests, especially for patients with G6PD deficiency or other blood disorders, to monitor for rare side effects.  

For best results, Aczone should be used consistently. Stopping too soon can allow symptoms to return. Do not combine Aczone with topical benzoyl peroxide at the same time of day, as this may cause temporary skin discoloration. 

Does Aczone have a generic version? 

Yes. Aczone (dapsone) is available in FDA-approved generic forms in the United States. These generics contain the same active ingredient, strength, and safety profile as the brand-name product. The generic dapsone gel is available in both 5% and 7.5% formulations and provides the same therapeutic benefits at a typically lower cost. 

Generic dapsone gel is as effective and safe as Aczone, available by prescription, and potentially covered by insurance or patient assistance. 

Conclusion 

Aczone (dapsone) offers a powerful yet gentle solution for managing acne, especially for patients who have not found success with other treatments. By addressing both bacteria and inflammation, it helps reduce breakouts, prevent new acne formation, and improve skin clarity over time. 

Aczone effectively treats acne, but follow doctor’s orders and report any unusual symptoms, especially with blood disorders or G6PD deficiency. Consistent use and dermatologic follow-ups ensure safety and efficacy, leading to clearer skin and increased confidence. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Aczone (dapsone) gel prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Dapsone (topical route) description and precautions. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Dapsone topical: Drug information. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Topical dapsone for acne management. Retrieved from https://www.nih.gov 

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Brand Information

Aczone (dapsone)
1INDICATIONS AND USAGE
ACZONE
2DOSAGE AND ADMINISTRATION
For topical use only. Not for oral, ophthalmic, or intravaginal use.
After the skin is gently washed and patted dry, apply approximately a pea-sized amount of ACZONE Gel, 7.5%, in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other affected areas once daily. Rub in ACZONE Gel, 7.5%, gently and completely.
If there is no improvement after 12 weeks, treatment with ACZONE Gel, 7.5% should be reassessed.
3DOSAGE FORMS AND STRENGTHS
Gel, 7.5%. Each gram of ACZONE Gel, 7.5% contains 75 mg of dapsone in an off-white to yellow gel with suspended particles.
4CONTRAINDICATIONS
None.
5DRUG INTERACTIONS
No formal drug-drug interaction studies were conducted with ACZONE Gel, 7.5%.
5.1Trimethoprim-Sulfamethoxazole
A drug-drug interaction study evaluated the effect of the use of dapsone gel, 5% in combination with double strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemic levels of TMP and SMX were essentially unchanged, however, levels of dapsone and its metabolites increased in the presence of TMP/SMX. The systemic exposure from ACZONE Gel, 7.5% is expected to be about 1% of that from the 100 mg oral dose, even when co-administered with TMP/SMX.
5.2Topical Benzoyl Peroxide
Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discoloration of the skin and facial hair.
5.3Drug Interactions with Oral Dapsone
Certain concomitant medications (such as rifampin, anticonvulsants, St. John’s wort) may increase the formation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions.
5.4Concomitant Use with Drugs that Induce Methemoglobinemia
Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia
6DESCRIPTION
ACZONE (dapsone) Gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. ACZONE Gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone has an empirical formula of C
Chemical Structure
Each gram of ACZONE Gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water.
7CLINICAL STUDIES
The safety and efficacy of once daily use of ACZONE Gel, 7.5%, was assessed in two 12-week multicenter, randomized, double-blind, vehicle-controlled trials. Efficacy was assessed in a total of 4340 subjects 12 years of age and older. The majority of the subjects had moderate acne vulgaris, 20 to 50 inflammatory and 30 to 100 non-inflammatory lesions at baseline, and were randomized to receive either ACZONE Gel, 7.5% or vehicle.
Treatment response was defined at Week 12 as the proportion of subjects who were rated “none” or “minimal” with at least a two-grade improvement from baseline on the Global Acne Assessment Score (GAAS), and mean absolute change from baseline in both inflammatory and non-inflammatory lesion counts. A GAAS score of “none” corresponded to no evidence of facial acne vulgaris. A GAAS score of “minimal” corresponded to a few non-inflammatory lesions (comedones) being present and to a few inflammatory lesions (papules/pustules) that may be present.
The GAAS success rate, mean reduction, and percent reduction in acne lesion counts from baseline after 12 weeks of treatment are presented in the following table.
8HOW SUPPLIED/STORAGE AND HANDLING
ACZONE Gel is an off-white to yellow gel with suspended particles. It is supplied in an airless pump containing a polypropylene bottle with a high density polyethylene piston.
ACZONE (dapsone) Gel, 7.5%, is supplied in the following sizes:
          NDC 16110-526-30                    30 gram pump
          NDC 16110-526-60                    60 gram pump
          NDC 16110-526-90                    90 gram pump
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Hematological Effects
  • Inform patients that methemoglobinemia can occur with topical dapsone treatment. Advise patients to seek immediate medical attention if they develop cyanosis
  • 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
Important Administration Instructions
  • Advise patients to apply ACZONE Gel, 7.5%, once daily to the entire face
  • ACZONE Gel, 7.5% is for topical use only.
  • Do not apply ACZONE Gel, 7.5% to eyes, mouth, or mucous membranes.
Distributed by: Almirall, LLC.
Malvern, PA 19355
Aczone
© 2019 Almirall, LLC. All rights reserved.
10PRINCIPAL DISPLAY PANEL - NDC: 16110-526-60 - 60 g Pump Label
60 g Pump Label
11PRINCIPAL DISPLAY PANEL - NDC: 16110-526-60 - 60 g Carton Label
60 g Carton Label
12PRINCIPAL DISPLAY PANEL - NDC: 16110-526-90 - 90 g Pump Label
90 g Pump Label
13PRINCIPAL DISPLAY PANEL - NDC: 16110-526-90 - 90 g Carton Label
90 g Carton Label