Uses
Dapsone gel, 5%, is indicated for the topical treatment of acne vulgaris. Dapsone gel is indicated for the topical treatment of acne vulgaris.
Source: US FDA prescribing information
- Presentations
- 5
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Dapsone is a sulfone indicated for the topical treatment of acne vulgaris. It is available as tablets and gel for oral and topical use. MedsAcross supplies Dapsone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Sulfone
- ATC classification
- D10AX05 Dapsone · Acne treatments, subgroup D10A, subgroup D10AXJ04BA02 Dapsone · Leprostatic agent, subgroup J04BA
- US FDA first approval
- 7 July 2005
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral, Topical
- Dosage forms
- Tablet, Gel
- Identifiers
- UNII 8W5C518302RxCUI 3108CAS 80-08-0DrugBank DB00250Q422226
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
The mechanism of action of dapsone gel in treating acne vulgaris is not known.
Source: US FDA prescribing information
Dosing overview
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 dapsone gel, 5%, in a thin layer to the acne affected areas twice daily. Rub in dapsone gel, 5%, gently and completely. Dapsone gel, 5%, is gritty with visible drug substance particles. Wash hands after application of dapsone gel, 5%. If there is no improvement after 12 weeks, treatment with dapsone gel, 5%, should be reassessed. Apply twice daily. Apply approximately a pea-sized amount of dapsone gel, 5%, in a thin layer to the acne affected area. For topical use only.
Source: US FDA prescribing information
Contraindications
None. None.
Source: US FDA prescribing information
Warnings and precautions
Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue dapsone gel if signs of methemoglobinemia occur. Hematologic Effects: Some subjects with G6PD deficiency using dapsone gel developed laboratory changes suggestive of hemolysis.
Source: US FDA prescribing information
Side effects
Most common adverse reactions (incidence ≥ 10%) are oiliness/peeling, dryness and erythema at the application site.
Source: US FDA prescribing information
Interactions
Trimethoprim/sulfamethoxazole (TMP/SMX) increases the level of dapsone and its metabolites. Topical benzoyl peroxide used at the same time as dapsone may result in temporary local yellow or orange skin discoloration.
Source: US FDA prescribing information
Storage
Store dapsone gel at controlled room temperature, 20°-25°C (68°-77°F), excursions permitted to 15°-30ºC (59°-86ºF). Protect from freezing.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
5 presentations of Dapsone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Dapsone 100 mg tabletOralGeneric name | — | US FDA | Available on request |
| Dapsone 25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Dapsone 7.5% gelTopicalGeneric name | — | US FDA | Available on request |
| Dapsone 5% gelTopicalGeneric name | — | US FDA | Available on request |
| Aczone 7.5% gelTopical | Almirall | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 7 July 2005 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Dapsone in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Dapsone available for export from India?
Yes, on request. MedsAcross lists 5 presentations of Dapsone and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Dapsone have?
The catalogue lists 1 brand names for Dapsone, including Aczone.
Is Dapsone approved by the US FDA?
Yes. The US FDA first approved Dapsone on 7 July 2005, according to Drugs@FDA.
Does Dapsone need cold chain shipping?
No listed presentation of Dapsone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Dapsone in?
Dapsone is classified under ATC code D10AX05 (Dapsone).
References
- DAPSONE prescribing information (Pacific Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 30 September 2018
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