a once-a-day prescription acne product1
Important safety information prescribing information

READY FOR A CLINICALLY PROVEN ACNE TREATMENT?1

Your dermatologist can prescribe once daily ACZONE® (dapsone) Gel, 7.5%.1

The formulationthe acne brand with topical dapsone.2

It's a non-retinoid, BPO-free prescription acne treatment with 7.5% topical dapsone.1

ACZONE® Gel, 7.5% is clinically proven to treat acne.1

  1. Use once a day,1 any time that best suits your routine
  2. Treats inflammatory and non-inflammatory acne1
  3. ACZONE® does not contain benzoyl peroxide1
  4. ACZONE® is not a retinoid1

Important Safety Information

What is ACZONE® Gel?

ACZONE® Gel, 7.5%, is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older.

ACZONE® Gel, 7.5%, has not been studied in children under 12 years of age.

What should I tell my doctor before using ACZONE® Gel, 7.5%?

Before you use ACZONE® Gel, 7.5%, tell your doctor about all of your medical conditions, including if you:

  • have a 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, 7.5%, may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. ACZONE® Gel, 7.5%, can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use ACZONE® Gel, 7.5%, 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, 7.5% at the same time may cause your skin or facial hair to temporarily turn yellow or orange at the site of application.

What are the possible side effects of ACZONE® Gel, 7.5%?

ACZONE® Gel, 7.5% 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, 7.5% 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, 7.5% may develop mild hemolytic anemia. Stop using ACZONE® Gel, 7.5% and tell your doctor right away if you get any of the following signs and symptoms:
    • back pain
    • dark brown urine
    • shortness of breath
    • fever
    • tiredness or weakness
    • yellow or pale skin

The most common side effects of ACZONE® Gel, 7.5% include dryness and itching of the skin being treated.

These are not all of the possible side effects of ACZONE® Gel, 7.5%. 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, 7.5%?

  • Store ACZONE® Gel, 7.5%, at room temperature 68ºF to 77ºF (20ºC to 25ºC).
  • Protect ACZONE® Gel, 7.5% from freezing.

Keep ACZONE® Gel, 7.5% and all medicines out of the reach of children.

General information about the safe and effective use of ACZONE® Gel, 7.5%

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ACZONE® Gel, 7.5% for a condition for which it was not prescribed. Do not give ACZONE Gel, 7.5% to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about ACZONE® Gel, 7.5% that is written for health professionals.

ACZONE® (dapsone) GEL, 7.5% IMPORTANT INFORMATION
APPROVED USE

ACZONE® (dapsone) Gel, 7.5% is a prescription medicine used on the 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 and facial hair to temporarily turn yellow or orange at the site of application.

ACZONE® Gel 7.5% 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 gray or blue, stop using ACZONE® Gel 7.5% and get medical help right away.
  • A breakdown of red blood cells (hemolytic anemia) for some people with G6PD deficiency using ACZONE® Gel 7.5%. Stop using ACZONE® Gel 7.5%, and call your doctor right away if you get any of the following signs and symptoms: back pain, breathlessness, tiredness/weakness, dark‑brown urine, fever, or yellow or pale skin.

The most common side effects of ACZONE® Gel are dryness and itching 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 Prescribing Information.

References:

1. ACZONE® 7.5% Prescribing Information.

2. U.S. Food and Drug Administration (FDA). Orange book: approved drug products with therapeutic equivalence evaluations. Available at: http://www.accessdata.fda.gov/scripts/cder/ob/. Accessed December 7, 2018.

ACZONE® (dapsone) Gel, 7.5% is a prescription medicine used on the 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 and facial hair to temporarily turn yellow or orange at the site of application.

ACZONE® Gel 7.5% 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 gray or blue, stop using ACZONE® Gel 7.5% and get medical help right away.
  • A breakdown of red blood cells (hemolytic anemia) for some people with G6PD deficiency using ACZONE® Gel 7.5%. Stop using ACZONE® Gel 7.5%, and call your doctor right away if you get any of the following signs and symptoms: back pain, breathlessness, tiredness/weakness, dark-brown urine, fever, or yellow or pale skin.

The most common side effects of ACZONE® Gel are dryness and itching 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 Prescribing Information.

References:

1. ACZONE® 7.5% Prescribing Information.

2. U.S. Food and Drug Administration (FDA). Orange book: approved drug products with therapeutic equivalence evaluations. Available at: http://www.accessdata.fda.gov/scripts/cder/ob/. Accessed December 7, 2018.