Tell your doctor about all of your medical conditions, including if you:

• are pregnant or planning to become pregnant. It is not known if ACZONE^® (dapsone) Gel 5% may harm your unborn baby. You and your doctor will need to decide if ACZONE^® Gel is right for you.
• are breastfeeding. ACZONE^® Gel passes into your milk and may harm your baby. You should choose either to use ACZONE^® Gel, or breastfeed, but not both. Talk to your doctor about the best way to feed your baby while using ACZONE^® Gel.
• have glucose-6-phosphate dehydrogenase deficiency.

Tell your doctor about all the medicines you are taking including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are using any other medicines applied to the skin, such as acne medicines with benzoyl peroxide.

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.

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 dapsone (the active ingredient of ACZONE^® Gel) 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 (such as the 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.

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

This is not a complete list of all the possible side effects. Call your doctor if you have any side effects that do not go away or that bother you. If you have any questions, ask your doctor or pharmacist.

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

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.