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Read this important information before you start using Aczone gel and each time you refill your prescription. There may be new information that you need to know. This summary is not meant to take the place of your doctor's advice. If you have any questions or want more information about Aczone gel 5%, ask your doctor, pharmacist, or other healthcare professional.

What is Aczone (Dapsone) gel?

Aczone (Dapsone) gel 5% is a prescription medicine used on your skin (topical) to treat acne in people 12 years and older.

Dapsone (Aczone) has not been studied in children under 12 years of age.

Who should not use Dapsone (Aczone) gel?

Do not use Dapsone (Aczone) gel 5% if you are allergic to any of the ingredients in Aczone or if you are younger than 12 years of age.

Active ingredient: dapsone.

Inactive ingredients: Carbomer 980, methylparaben, diethylene glycol monoethyl ether (DGME), sodium hydroxide, and purified water.

What should I tell my doctor before using Aczone gel?

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

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

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

    How do I use Dapsone (Aczone)?

  • Use Dapsone (Aczone) gel exactly as prescribed by your doctor. This medication is usually used on your affected skin twice a day, once in the morning and once in the evening.
  • Apply a thin layer of Aczone to the areas of your skin that have acne. A pea-sized amount of the medicine will usually be enough.
  • Wash the areas of your skin where you will apply Dapsone (Aczone) gel 5%. Gently pat your skin dry with a clean towel.
  • Rub Aczone gel in gently and completely
  • Wash your hands after applying Aczone (Dapsone) gel.
  • Make sure to put the cap back on the Aczone gel 5% tube. Close it tightly.
  • Keep Aczone (Dapsone) gel 5% away from your mouth and eyes. Do not swallow this drug. If you swallow Dapsone (Aczone), call your healthcare provider or poison control center right away.
  • If your acne does not get better after using Dapsone (Aczone) gel for 12 weeks, talk to your doctor or pharmacist about other treatments for acne.

    What are the possible side effects of Dapsone (Aczone) gel 5%?

    Like all medicines, Aczone 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 (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-phoshate dehydrogenase deficiency, you may have a greater risk for lowering your hemoglobin level. However, using Aczone gel 5% 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 or physician immediately.

    Use of benzoyl peroxide together with Aczone (Dapsone) gel at the same time 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 healthcare provider if you have any side effects that do not go away or bother you. If you have any questions, ask your physician or pharmacist.

    How should I store Dapsone (Aczone) gel?

    Store Dapsone (Aczone) gel 5% at room temperature 68 to 76°F. Do not freeze Aczone.

    Keep Aczone gel out of the reach of children less than 12 years of age.

    Where can I find more information about Aczone gel 5%?

    If you have any questions or want more information about Aczone (Dapsone) gel, ask your doctor, pharmacist, or other healthcare professional. Your physician or pharmacist can also give you a copy of the Aczone (Dapsone) gel 5% Package Insert written for health professionals. Ask them to explain anything you do not understand.

    Manufactured and distributed by Allergan, Tolmar pharmaceutical companies and its divisions.

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