Important safety information prescribing information for healthcare professionals

READY FOR A CLINICALLY PROVEN ACNE TREATMENT?1

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

The formulationthe only 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 4 types of acne1,3
  3. ACZONE® does not contain benzoyl peroxide1
  4. ACZONE® is not a retinoid1

The next steptreating your acne.

Acne is a chronic condition and the most common skin problem in the United States.4 It affects both men and women, and can happen at any age—but you can successfully treat your acne.5,6

Why ACZONE® Gel, 7.5%?

Once a day, any time1

Available for use just
once a day

One product.
One pea-sized amount.
Once a day.

The only acne brand with topical dapsone2

ACZONE® Gel is not:

  • a BPO
  • a retinoid

May cost less than you think, thanks to the ACZONE® Savings Program

Save on ACZONE® Gel

With our ACZONE® Savings Program, prescription treatment may cost less than you think. Download your savings card and start saving today!

12 Weeks

ACZONE® Gel reduces acne in just 12 weeks1

ACZONE® Gel, 7.5% works
in just 12 weeks1

Clinical studies have proven that patients who use ACZONE® Gel, 7.5% saw an improvement in their acne in 12 weeks.1

See resultsACZONE® gel, 7.5% reduces acne.1

It has been proven to treat 4 types of acne in a large clinical study which included 4,340 patients.1,3

In clinical trials, the most common side effects associated with ACZONE® Gel, 7.5% were dryness and itching of the skin being treated.

View the photo gallery to see how ACZONE® Gel, 7.5% has helped reduce acne in people just like you.*

Gabriela
Kate
Lynn
Tyler

*The patients depicted are real patients. Their names have been changed. Actual results may vary.

aczone® gel, 7.5% is only available by prescription.

Talk to your dermatologist. If you don't have one, find one here.

Safety & Side Effects

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.

For more information call 1-800-433-8871.

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 Product 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 January 19, 2016.

3. Data on file, Allergan, 2015.

4. American Academy of Dermatology. Acne. Available at: https://www.aad.org/ media/ stats/ conditions. Accessed January 19, 2016.

5. American Academy of Dermatology. Acne: who gets and causes. Available at: https://www.aad.org/ public/ diseases/ acne-and-rosacea/ acne. Accessed January 19, 2016.

6. American Academy of Dermatology. Acne: diagnosis and treatment. Available at: https://www.aad.org/ public/ diseases/ acne-and-rosacea/ acne. Accessed January 19, 2016.

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 Product 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 January 19, 2016.

3. Data on file, Allergan, 2015.

4. American Academy of Dermatology. Acne. Available at: https://www.aad.org/ media/ stats/ conditions. Accessed January 19, 2016.

5. American Academy of Dermatology. Acne: who gets and causes. Available at: https://www.aad.org/ public/ diseases/ acne-and-rosacea/ acne. Accessed January 19, 2016.

6. American Academy of Dermatology. Acne: diagnosis and treatment. Available at: https://www.aad.org/ public/ diseases/ acne-and-rosacea/ acne. Accessed January 19, 2016.