ACZONE (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

ACZONE (dapsone) Gel, 5%, is supplied in the following size tubes:

NDC 0023-3670-30

30 gram laminate tube

NDC 0023-3670-60

60 gram laminate tube

NDC 0023-3670-90

90 gram laminate tube

Store ACZONE gel at controlled room temperature, 20°-25°C (68°-77°F), excursions permitted to 15°-30ºC (59°-86ºF). Protect from freezing.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hematological Effects

• Inform patients that methemoglobinemia can occur with topical dapsone treatment. Advise patients to seek immediate medical attention if they develop cyanosis [see Warnings and Precautions ( 5.1)].
  
• Inform patients who have G6PD deficiency that hemolytic anemia may occur with topical dapsone treatment. Advise patients to seek medical attention if they develop signs and symptoms suggestive of hemolytic anemia [see Warnings and Precautions ( 5.2)].

Important Administration Instructions

• Advise patients to apply ACZONE Gel, 5%, twice daily to the acne affected area [see Dosage and Administration (2)].
  
• ACZONE Gel, 5% is for topical use only.
• Do not apply ACZONE Gel, 5% to eyes, mouth, or mucous membranes.

Distributed by: Allergan USA, Inc.

Madison, NJ 07940

© 2018 Allergan. All rights reserved.

All trademarks are the property of their respective owners.

v1.0USPI3670

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PATIENT INFORMATION ACZONE ® ( AK-zōn ) (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 tak e , 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%. 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	○ fever	○ 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 68ºF to 77ºF (20ºC to 25ºC). 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: dapsoneInactive ingredients: carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide, and purified water, USP.Distributed by: Allergan USA, Inc.Madison, NJ 07940© 2018 Allergan. All rights reserved. All trademarks are the property of their respective owners. v1.0PPI3670For more information, call 1-800-678-1605

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 05/2018

PRINCIPAL DISPLAY PANEL

NDC 0023-3670-90
Aczone
(dapsone)gel, 5%
90 gRx Only

ACZONE dapsone gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-3670 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DAPSONE (DAPSONE) DAPSONE 50 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) DIETHYLENE GLYCOL MONOETHYL ETHER METHYLPARABEN SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0023-3670-03 15 TUBE in 1 CARTON contains a TUBE 1 3 g in 1 TUBE This package is contained within the CARTON (0023-3670-03) 2 NDC:0023-3670-30 1 TUBE in 1 CARTON contains a TUBE 2 30 g in 1 TUBE This package is contained within the CARTON (0023-3670-30) 3 NDC:0023-3670-60 1 TUBE in 1 CARTON contains a TUBE 3 60 g in 1 TUBE This package is contained within the CARTON (0023-3670-60) 4 NDC:0023-3670-90 1 TUBE in 1 CARTON contains a TUBE 4 90 g in 1 TUBE This package is contained within the CARTON (0023-3670-90)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021794 06/24/2009

Labeler — Allergan, Inc. (144796497)

Revised: 05/2018 Allergan, Inc.