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ACZONE® (dapsone) Gel 5%

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

Acne vulgaris, or acne, is a common skin disorder.1 Acne treatment depends on whether a patient has a mild, moderate, or severe form. Fortunately, acne is also one of the most treatable skin conditions once a physician and patient find an appropriate product and dosage.

ACZONE® Gel is the first new chemical entity approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of acne in more than a decade and works fast, especially on inflammatory acne,2 with notable results in as early as two weeks.1 Combining dapsone in a Solvent Microparticulate™ gel enables dapsone to be applied topically. Allergan launched ACZONE® Gel 5% in November 2008.

Ask your doctor if ACZONE® Gel is right for you.

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.

Please see Full ACZONE® Product Information 
ACZONE® Web site 



  1. National Institute of Arthritis and Musculoskeletal and Skin Diseases. National Institutes of Health. What is acne? Fast facts: an easy-to-read series of publications for the public. Available at: http://www.niams.nih.gov/health_info/acne/default.asp#acne_d. Accessed October 31, 2008.
  2. Draelos ZD, Carter E, Maloney JM, et al; for the 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.