ACZONE^® (dapsone) Gel 5% is approved for the topical treatment of acne vulgaris.

IMPORTANT SAFETY INFORMATION

Do not use ACZONE^® Gel if you are allergic to any of the ingredients in ACZONE^® Gel or if you are younger than 12 years of age.

Tell your doctor about all of your medical conditions, including if you have glucose-6-phosphate dehydrogenase deficiency.

Like all medicines, ACZONE^® Gel can cause some side effects. The most common side effects of ACZONE^® Gel are dryness, redness, oiliness, and peeling of the skin being treated.

When the active ingredient of ACZONE^® Gel (called dapsone) is taken orally as a pill, it has been related to the abnormal breakdown of red blood cells (hemolytic anemia). If you have glucose-6-phosphate dehydrogenase deficiency, you may have a greater risk for lowering your hemoglobin level. However, using ACZONE^® Gel on the skin is not expected to put enough dapsone in the blood to cause clinical symptoms of hemolytic anemia. You are advised to be alert for signs and symptoms suggestive of this type of anemia (sudden onset of: back pain, breathlessness, tiredness/weakness with daily activities, dark-brown urine, high fever, and yellow or pale skin). If you experience these signs and symptoms, stop use and call your doctor immediately.

Use of benzoyl peroxide together with ACZONE^® Gel at the same time may cause your skin to temporarily turn yellow or orange at the site of application.

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