APPROVED USE

ACZONE^® Gel is a prescription medicine used on your skin (topical) to treat acne in people 12 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 or facial hair to temporarily turn yellow or orange at the site of application.

ACZONE^® Gel, 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 grey or blue, stop using ACZONE^® Gel 5% and get medical help right away.

• a breakdown of red blood cells (hemolytic anemia) for some people with G6PD deficiency using ACZONE^® Gel 5%. If you get any of the following signs and symptoms such as back pain, breathlessness, tiredness/weakness, dark-brown urine, fever, and yellow or pale skin, stop using ACZONE^® Gel 5% and call your doctor right away.

The most common side effects of ACZONE^® Gel are dryness, redness, oiliness, and peeling 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 Product Information.

REFERENCES:
1. IMS Health, Inc. Vector One^®: National (VONA). Plymouth Meeting, PA; IMS Health, Inc.; Total prescriptions filled for non-retinoid acne treatments between February 2014–January 2015.
2. ACZONE^® Prescribing Information.
3. Draelos ZD, Carter E, Maloney JM, et al; for United States/Canada Dapsone Gel Study Group. Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris. J Am Acad Dermatol. 2007;56(3):439.e1-439.e10.