Dapsone

What it is and how it works

Mechanism of Action The mechanism of action of dapsone gel in treating acne vulgaris is not known.

Indications

Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris. Dapsone Gel is indicated for the topical treatment of acne vulgaris .

Dosage and administration (summary)

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 .

Contraindications

None. None .

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. . Methemoglobinemia Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with dapsone gel, 5% treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia.

Pregnancy

Pregnancy Risk Summary There are no available data on dapsone gel, 5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 250 times the systemic ex…

Storage and supply

Dapsone gel, 5%, is supplied in the following size tubes: Strength NDC Number 30 g laminated tube 46708-551-30 60 g laminated tube 46708-551-60 90 g laminated tube 46708-551-90 Store dapsone gel at controlled room temperature, 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30ºC (59° to 86ºF). Protect from freezing.

Source: Dapsone (Dapsone) — US FDA prescribing information, 2026-07-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.