Dapsone Gel 5% - 60g, 90g

  • Dapsone Gel 5% is bioequivalent (similar) to the brand ACZONE® Gel 5%, another product used to treat acne in people 12 years of age and older.
  • Dapsone Gel 5% is not a retinoid and does not contain benzoyl peroxide. It contains the active ingredient dapsone, a sulfone agent that helps slow or stop the growth of bacteria that cause acne.
  • Dapsone Gel 5% is formulated in a cosmetically elegant and easy-to-spread gel that is applied to affected skin in a thin layer twice daily (morning and evening).

Important Information

Indication

Dapsone Gel, 5% is a prescription medicine used on the skin (topical) to treat acne.

Important Safety Information

  • Do not use Dapsone Gel if you are allergic to any of its ingredients.
  • Tell your doctor about all of your medical conditions, including if you have glucose-6 phosphate dehydrogenase deficiency (G6PD) or higher than normal levels of levels of methemoglobin in your blood (methemoglobinemia).
  • Stop using Dapsone Gel and get medical help right away if your lips, nail beds, or the inside of your mouth turns grey or blue.
  • Stop using Dapsone Gel and tell your doctor right away if you get any of the following signs/symptoms: back pain, shortness of breath, tiredness/weakness, dark brown urine, fever, yellow/pale skin.
  • Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.
  • Tell your doctor about all the medicines you take, especially medicines including benzoyl peroxide. Use of Dapsone Gel and benzoyl peroxide at the same time may cause your skin or hair to temporarily turn yellow or orange at the site of application.
  • The most common side effects of Dapsone Gel include oiliness, peeling, dryness, and redness of the skin being treated.
  • Dapsone Gel is for external use only. Avoid contact with the eyes, mouth, vagina and other mucous membranes.
  • Clinical data has not been established for pregnant women treated with Dapsone Gel.
  • Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

For additional safety and other information, including Patient Information, please see FULL PRESCRIBING INFORMATION. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit WWW.FDA.GOV/MEDWATCH, or call 1-800-FDA-1088.