ACZONE ^®(dapsone) Gel 7.5% is indicated for the topical treatment of acne vulgaris in patients aged 9 years and older.

ACZONE^® (dapsone) GEL, 7.5% IMPORTANT INFORMATION

APPROVED USE

ACZONE^® (dapsone) Gel, 7.5% is a prescription medicine used on the skin (topical) to treat acne in people 9 years and older.

IMPORTANT SAFETY INFORMATION

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 methemoglobin in your blood (methemoglobinemia).

Talk to your doctor about any medications you’re using, including topical benzoyl peroxide (BPO). Use of BPO with ACZONE^® Gel may cause your skin and facial hair to temporarily turn yellow or orange at the site of application.

ACZONE^® Gel 7.5% may cause serious side effects, including:

• A decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia). If your lips, nail beds, or the inside of your mouth turns gray or blue, stop using ACZONE^® Gel 7.5% and get medical help right away.
• A breakdown of red blood cells (hemolytic anemia) for some people with G6PD deficiency using ACZONE^® Gel 7.5%. Stop using ACZONE^® Gel 7.5%, and call your doctor right away if you get any of the following signs and symptoms: back pain, breathlessness, tiredness/weakness, dark‑brown urine, fever, or yellow or pale skin.

The most common side effects of ACZONE^® Gel are dryness and itching of the skin being treated.

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.

Please click here for the full Prescribing Information.