"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
(dapsone) Gel, 5%
Important: For use on skin only (topical use). Do not use ACZONE® Gel, 5% in or on your mouth, eyes, or vagina.
What is ACZONE® Gel, 5%?
ACZONE® Gel, 5% is a prescription medicine used on your skin (topical) to treat acne vulgaris.
ACZONE® Gel has not been studied in children under 12 years of age.
Before using ACZONE® Gel, 5%, tell your doctor about all of your medical conditions, including if you:
- Have glucose-6-phosphate dehydrogenase deficiency (G6PD)
- Have higher than normal levels of methemoglobin in your blood (methemoglobinemia)
- Are pregnant or plan to become pregnant. It is not known if ACZONE® Gel, 5 % will harm your unborn baby.
- Are breastfeeding or plan to breastfeed. ACZONE® Gel, 5% can pass into your breast milk and may harm your baby.
- You and your doctor should decide if you will use ACZONE® Gel, 5% or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you are using acne medicines that contain benzoyl peroxide. Use of benzoyl peroxide with ACZONE® Gel, 5% at the same time may cause your skin or facial hair to temporarily turn yellow or orange at the site of application.
How should I use ACZONE® Gel, 5%?
- Use ACZONE® Gel, 5% exactly as your doctor tells you.
- Apply ACZONE® Gel, 5% twice a day.
- Gently wash and pat dry the areas of your skin where you will apply ACZONE® Gel, 5%.
- Apply a pea-sized amount of ACZONE® Gel, 5% in a thin layer to the areas of your skin that have acne.
- Rub ACZONE® Gel, 5% in gently and completely. It may feel gritty and you may see particles in the gel.
- Make sure to put the cap back on the ACZONE® Gel tube. Close it tightly.
- Wash your hands after applying ACZONE® Gel, 5%.
- Do not swallow ACZONE® Gel. If you swallow ACZONE® Gel, call your doctor or poison control center right away.
- If your acne does not get better after using ACZONE® Gel, 5% for 12 weeks, talk to your doctor about continuing treatment.
What are the possible side effects of ACZONE® Gel, 5%?
ACZONE® Gel, 5% may cause serious side effects, including:
- Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell methemoglobinemia). Stop using ACZONE® Gel, 5% and get medical help right away if your lips, nail beds, or the inside of your mouth turns grey or blue.
- Breakdown of red blood cells (hemolytic anemia). Some
people with G6PD deficiency using ACZONE® Gel, 5% have developed mild
hemolytic anemia. Stop using ACZONE® Gel, 5% and tell your doctor right
away if you get any of the following signs and symptoms:
- back pain
- shortness of breath
- tiredness or weakness
- dark brown urine
- yellow or pale skin
The most common side effects of ACZONE® Gel, 5% include oiliness, peeling, dryness, and redness of the skin being treated.
These are not all of the possible side effects of ACZONE® Gel, 5%. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ACZONE® Gel, 5%?
- Store ACZONE® Gel, 5% at room temperature 68°F to 77°F (20°C to 25°C).
- Protect ACZONE® Gel, 5% from freezing.
Keep ACZONE® Gel, 5% and all medicines out of the reach of children.
General information about the safe and effective use of ACZONE® Gel, 5%?
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ACZONE® Gel, 5% for a condition for which it was not prescribed. Do not give ACZONE® Gel, 5% to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about ACZONE® Gel, 5% that is written for health professionals.
What are the ingredients in ACZONE® Gel, 5%?
Active ingredient: dapsone
Inactive ingredients: carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide, and purified water, USP.
Last reviewed on RxList: 2/4/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Aczone Gel Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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