HIGHLIGHTS OF PRESCRIBING INFORMATION
`These highlights do not include all the information
`needed to use ACZONE® Gel, 7.5% safely and
`effectively. See full prescribing information for
`ACZONE® Gel, 7.5%.
`
`ACZONE® (dapsone) Gel, 7.5%, for topical use
`Initial U.S. Approval: 1955
`
`INDICATIONS AND USAGE
`ACZONE® Gel, 7.5%, is a sulfone indicated for the topical
`treatment of ache vulgaris in patients 12 years of age and
`older (1).
`
`DOSAGE AND ADMINISTRATION---
`¯ Apply once daily (2).
`¯ Apply approximately a pea-sized amount of ACZONE
`Gel, 7.5%, in a thin layer to the entire face. A thin layer can
`also be applied to other affected areas (2).
`¯ If there is no improvement after 12 weeks, treatment with
`ACZONE Gel, 7.5% should be reassessed (2).
`¯ For topical use only. Not for oral, ophthalmic, or
`intravaginal use (2).
`
`---DOSAGE FORMS AND STRENGTHS--
`Gel, 7.5% (3).
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`1
`INDICATIONS AND USAGE
`2 DOSAGE AND ADMINISTRATION
`3 DOSAGE FORMS AND STRENGTHS
`4 CONTRAINDICATIONS
`5 WARNINGS AND PRECAUTIONS
`5.1 Hematological Effects
`5.2 Peripheral Neuropathy
`Skin Reactions
`5.3
`6 ADVERSE REACTIONS
`6.1 Clinical Studies Experience
`6.2 Experience with Oral Use of Dapsone
`Postmarketing Experience
`6.3
`7 DRUG INTERACTIONS
`Trimethoprim-Sulfamethoxazole
`7.1
`7.2 Topical Benzoyl Peroxide
`7.3 Drug Interactions with Oral Dapsone
`7.4 Concomitant Use with Drugs that Induce
`Methemoglobinemia
`
`CONTRAINDICATIONS
`
`None (4).
`
`WARNINGS AND PRECAUTIONS
`¯ Methemoglobinemia: Cases of methemoglobinemia have
`been reported. Discontinue ACZONE Gel if signs of
`methemoglobinemia occur (5.1).
`¯ Hemolysis: Some patients with Glucose-6-phosphate
`Dehydrogenase (G6PD) deficiency using topical dapsone
`developed laboratory changes suggestive of hemolysis
`(5.1)(8.6).
`
`-ADVERSE REACTIONS-
`Most common (incidence _> 0.9%) adverse reactions are
`application site dryness and pruritus (6.1).
`
`To report SUSPECTED ADVERSE REACTIONS,
`contact Allergan at 1-800-433-8871 or FDA at 1-800-
`FDA-1088 or www.fda.gov/medwatch.
`
`DRUG INTERACTIONS
`¯ Trimethoprim/sulfamethoxazole (TMP/SMX) increases
`the systemic level of dapsone and its metabolites (7.1).
`¯ Topical benzoyl peroxide used at the same time as
`ACZONE Gel, 7.5% may result in temporary local yellow
`or orange skin discoloration (7.2).
`
`See 17 for PATIENT COUNSELING INFORMATION
`and FDA-approved patient labeling.
`
`Revised: 02/2016
`
`8 USE IN SPECIFIC POPULATIONS
`8.1
`Pregnancy
`8.3 Nursing Mothers
`8.4 Pediatric Use
`8.5 Geriatric Use
`8.6 Glucose-6-phosphate Dehydrogenase (G6PD)
`Deficiency
`11 DESCRIPTION
`12 CLINICAL PHARMACOLOGY
`12.1 Mechanism of Action
`12.3 Pharmacokinetics
`12.4 Microbiology
`13 NONCLINICAL TOXICOLOGY
`13.1 Carcinogenesis, Mutagenesis,
`Impairment of Fertility
`14 CLINICAL STUDIES
`16 HOW SUPPLIED/STORAGE AND
`HANDLING
`17 PATIENT COUNSELING INFORMATION
`
`* Sections or subsections omitted from the full prescribing
`information are not listed.
`
`1 of 10
`
`Almirall EXHIBIT 2039
`Amneal v. Almirall
`IPR2018-00608
`
`AMN1061
`Amneal v. Almirall, LLC
`IPR2019-00207
`
`

`

`FULL PRESCRIBING INFORMATION
`
`INDICATIONS AND USAGE
`1
`ACZONE® (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 12 years of
`age and older.
`
`DOSAGE AND ADMINISTRATION
`2
`For topical use only. Not for oral, ophthalmic, or intravaginal use.
`
`After the skin is gently washed and patted dry, apply approximately a pea-sized amount of ACZONE Gel,
`7.5%, in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other affected areas
`once daily. Rub in ACZONE Gel, 7.5%, gently and completely.
`
`If there is no improvement after 12 weeks, treatment with ACZONE Gel, 7.5% should be reassessed (2).
`
`DOSAGE FORMS AND STRENGTHS
`3
`Gel, 7.5%. Each gram of ACZONE Gel, 7.5% contains 75 mg of dapsone in an off-white to yellow gel with
`suspended particles.
`
`CONTRAINDICATIONS
`
`4
`None.
`
`WARNINGS AND PRECAUTIONS
`5
`Hematological Effects
`5.1
`Methemoglobinemia
`Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association
`with twice daily dapsone gel, 5%, treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or
`congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia. Avoid
`use of ACZONE Gel, 7.5% in those patients with congenital or idiopathic methemoglobinemia.
`
`Signs and symptoms of methemoglobinemia may be delayed some hours after exposure. Initial signs and
`symptoms of methemoglobinemia are characterized by a slate grey cyanosis seen in e.g., buccal mucous
`membranes, lips, and nail beds. Advise patients to discontinue ACZONE Gel, 7.5% and seek immediate
`medical attention in the event of cyanosis.
`
`Dapsone can cause elevated methemoglobin levels particularly in conjunction with methemoglobin-inducing
`agents [see Drug Interactions (7. 4)].
`
`Hemolysis
`Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-
`phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PD
`deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean
`ancestry.
`
`In clinical trials, there was no evidence of clinically relevant hemolysis or hemolytic anemia in subj ects treated
`with topical dapsone. Some subjects with G6PD deficiency using dapsone gel, 5 %, twice daily developed
`laboratory changes suggestive of hemolysis [see Use in Specific Populations (8. 6)].
`
`Discontinue ACZONE Gel, 7.5%, if signs and symptoms suggestive of hemolytic anemia occur. Avoid use of
`ACZONE Gel, 7.5% in patients who are taking oral dapsone or antimalarial medications because of the
`
`2 ofl0
`
`

`

`potential for hemolytic reactions. Combination of ACZONE Gel, 7.5%, with trimethoprim/sulfamethoxazole
`(TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency [see Drug Interactions
`( 7.
`
`Peripheral Nenropathy
`5.2
`Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No
`events of peripheral neuropathy were observed in clinical trials with topical dapsone treatment.
`
`5.3 Skin Reactions
`Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions,
`bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone
`treatment. These types of skin reactions were not observed in clinical trials with topical dapsone treatment.
`
`ADVERSE REACTIONS
`6
`Clinical Studies Experience
`6.1
`Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the
`clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not
`reflect the rates observed in practice.
`
`A total of 2161 subj ects were treated with ACZONE Gel, 7.5%, for 12 weeks in 2 controlled clinical trials. The
`population ranged in age from 12 to 63 years, was 56% female, and 58% Caucasian. Adverse drug reactions
`that were reported in at least 0.9% of subjects treated with ACZONE Gel, 7.5% appear in Table 1 below.
`
`Table 1 Adverse Reactions Occurring in at Least 0.9% of Subjects with Acne Vulgaris in 12-week
`Controlled Clinical Trials
`ACZONE Gel, 7.5%
`(N=2161)
`24 (1.1%)
`
`Vehicle
`(N=2175)
`21 (1.0%)
`
`Application Site Dryness
`
`Application Site Pruritus
`
`20 (0.9%)
`
`11 (0.5%)
`
`Experience with Oral Use of Dapsone
`6.2
`Although not observed in the clinical trials with topical dapsone, serious adverse reactions have been reported
`with oral use of dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy (motor loss and
`muscle weakness), and skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and
`scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria).
`
`Postmarketing Experience
`6.3
`The following adverse reactions have been identified during post-approval use of topical dapsone. Because
`these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably
`estimate their frequency or establish a causal relationship to drug exposure.
`
`Methemoglobinemia has been identified during postmarketing use of topical dapsone [see Warnings and
`Precautions (5.1)].
`
`DRUG INTERACTIONS
`7
`No formal drug-drug interaction studies were conducted with ACZONE Gel, 7.5%.
`
`3 ofl0
`
`

`

`Trimethoprim-Sulfamethoxazole
`7.1
`A drag-drag interaction study evaluated the effect of the use of dapsone gel, 5% in combination with double
`strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemic
`levels of TMP and SMX were essentially unchanged, however, levels of dapsone and its metabolites increased
`in the presence of TMP/SMX. The systemic exposure from ACZONE Gel, 7.5% is expected to be about 1% of
`that from the 100 mg oral dose, even when co-administered with TMP/SMX.
`
`Topical Benzoyl Peroxide
`7.2
`Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a
`temporary local yellow or orange discoloration of the skin and facial hair.
`
`Drug Interactions with Oral Dapsone
`7.3
`Certain concomitant medications (such as rifampin, anticonvulsants, St. John’s wort) may increase the
`formation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsone
`treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of
`hematologic reactions.
`
`7.4 Concomitant Use with Drugs that Induce Methemoglobinemia
`Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides,
`acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites,
`nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital,
`phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings
`and Precautions (5.1)].
`
`USE IN SPECIFIC POPULATIONS
`8
`Pregnancy
`8.1
`Teratogenic Effects: Pregnancy Category C
`There are no adequate and well controlled studies in pregnant women. ACZONE Gel, 7.5%, should be used
`during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dapsone has been shown to
`have an embryocidal effect in rats and rabbits when administered orally during the period of organogenesis in
`doses of 75 mg/kg/day and 150 mg/kg/day, respectively (approximately 1400 and 425 times, respectively, the
`systemic exposure that is associated with the maximum recommended human dose (MRHD) of ACZONE Gel,
`7.5%, based on AUC comparisons). These effects may have been secondary to maternal toxicity.
`
`Nursing Mothers
`8.3
`Although systemic absorption of dapsone following topical application of ACZONE Gel, 7.5%, is minimal
`relative to oral dapsone administration, it is known that dapsone is excreted in human milk. Because of the
`potential for oral dapsone to cause adverse reactions in nursing infants, a decision should be made whether to
`discontinue nursing or to discontinue ACZONE Gel, 7.5%, taking into account the importance of the drug to
`the mother.
`
`Pediatric Use
`8.4
`Safety and efficacy was evaluated in 1066 subjects aged 12-17 years old treated with ACZONE Gel, 7.5% in
`the clinical trials. The safety profile for ACZONE Gel, 7.5%, was similar to the vehicle control group. Safety
`and effectiveness of ACZONE Gel, 7.5%, have not been established in pediatric patients below the age of 12
`years.
`
`4 ofl0
`
`

`

`Geriatric Use
`8.5
`Clinical trials of ACZONE Gel, 7.5% did not include sufficient numbers of subjects aged 65 years and over to
`determine whether they respond differently from younger subj ects.
`
`Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency
`8.6
`Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be more prone to
`methemoglobinemia and hemolysis [see Warnings and Precautions (5.1)].
`
`ACZONE Gel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical study
`of 64 subjects with G6PD deficiency and ache vulgaris. Subjects were Black (88%), Asian (6%), Hispanic (2%)
`or of other racial origin (5%). Blood samples were taken at Baseline, Week 2, and Week 12 during both vehicle
`and ACZONE Gel, 5% treatment periods. Some of these subj ects developed laboratory changes suggestive of
`hemolysis, but there was no evidence of clinically significant hemolytic anemia in this study [see Warnings and
`Precautions (5.1)].
`
`DESCRIPTION
`11
`ACZONE (dapsone) Gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic
`use. ACZONE Gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone has an
`empirical formula of C12H12N202S. It is a white or slightly yellow-white, crystalline powder that has a
`molecular weight of 248.30. Dapsone’s chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its
`structural formula is:
`
`NH2-~SO2-~NHz
`
`Each gram of ACZONE Gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl
`ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80,
`and purified water.
`
`12 CLINICAL PHARMACOLOGY
`12.1 Mechanism of Action
`The mechanism of action of dapsone gel in treating acne vulgaris is not known.
`
`12.3 Pharmacokinetics
`In a pharmacokinetic study, male and female subjects 16 years of age or older with ache vulgaris (N=19)
`received 2 grams of ACZONE Gel, 7.5%, topically to the face, upper chest, upper back and shoulders once
`daily for 28 days. Steady state for dapsone was reached within 7 days of dosing. On Day 28, the mean dapsone
`maximum plasma concentration (Cmax) and area under the concentration-time curve from 0 to 24 hours post
`dose (AUC0-24h) were 13.0 ± 6.8 ng/mL and 282 ± 146 ng.tVmL, respectively. The systemic exposure from
`ACZONE Gel, 7.5% is expected to be about 1% of that from a 100 mg oral dose.
`
`Long-term safety studies were not conducted with ACZONE Gel, 7.5%, however, in a long-term clinical study
`of dapsone gel, 5% treatment (twice daily), periodic blood samples were collected up to 12 months to determine
`systemic exposure of dapsone and its metabolites in approximately 500 subj ects. Based on the measurable
`dapsone concentrations from 408 subjects (M=192, F=216), obtained at Month 3, neither gender nor race
`appeared to affect the pharmacokinetics of dapsone. Similarly, dapsone exposures were approximately the same
`between the age groups of 12-15 years (N=155) and those greater than or equal to 16 years (N=253). There was
`no evidence of increasing systemic exposure to dapsone over the study year in these subjects.
`
`5 ofl0
`
`

`

`12.4 Microbiology
`In l/ivo Activity: No microbiology or immunology studies were conducted during ACZONE Gel, 7.5% clinical
`studies.
`
`Drug Resistance: No dapsone resistance studies were conducted during dapsone gel clinical studies. Because no
`such studies were done, there are no data available as to whether dapsone treatment may have resulted in
`decreased susceptibility of Propionibacterium aches, an organism associated with acne, or to other
`antimicrobials that may be used to treat acne. Therapeutic resistance to dapsone has been reported for
`Mycobacterium leprae, when patients have been treated with oral dapsone.
`
`13
`NONCLINICAL TOXICOLOGY
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`Dapsone was not carcinogenic to rats when orally administered for a lifetime at dose levels up to 15 mg/kg/day
`(approximately 340 times the systemic exposure that is associated with the MRHD of ACZONE Gel, 7.5%,
`based on AUC comparisons).
`
`No evidence of potential to induce carcinogenicity was obtained in a dermal study in which dapsone gel was
`topically applied to Tg.AC transgenic mice for approximately 26 weeks. Dapsone concentrations of 3%, 5%,
`and 10% were evaluated; 3% material was judged to be the maximum tolerated dosage.
`
`Topical gels that contained dapsone at concentrations up to 5% did not increase the rate of formation of
`ultraviolet light-induced skin tumors when topically applied to hairless mice in a 12-month
`photocarcinogenicity study.
`
`Dapsone was not mutagenic in a bacterial reverse mutation assay (Ames test) using S. typhimurium and E. coil,
`with and without metabolic activation, and was negative in a micronucleus assay conducted in mice. Dapsone
`increased both numerical and structural aberrations in a chromosome aberration assay conducted with Chinese
`hamster ovary (CH0) cells.
`
`The effects of dapsone on fertility and general reproduction performance were assessed in male and female rats
`following oral (gavage) dosing. Dapsone reduced sperm motility at dosages of 3 mg/kg/day or greater
`(approximately 22 times the systemic exposure that is associated with the MRHD of ACZONE Gel, 7.5%,
`based on AUC comparisons). The mean numbers of embryo implantations and viable embryos were
`significantly reduced in untreated females mated with males that had been dosed at 12 mg/kg/day or greater
`(approximately 187 times the systemic exposure that is associated with the MRHD of ACZONE Gel, 7.5%,
`based on AUC comparisons), presumably due to reduced numbers or effectiveness of sperm, indicating
`impairment of fertility. Dapsone had no effect on male fertility at dosages of 2 mg/kg/day or less
`(approximately 15 times the systemic exposure that is associated with the MRHD of ACZONE Gel, 7.5%,
`based on AUC comparisons). When administered to female rats at a dosage of 75 mg/kg/day (approximately
`1400 times the systemic exposure that is associated with the MRHD of ACZONE Gel, 7.5%, based on AUC
`comparisons) for 15 days prior to mating and for 17 days thereafter, dapsone reduced the mean number of
`implantations, increased the mean early resorption rate, and reduced the mean litter size. These effects were
`probably secondary to maternal toxicity.
`
`Dapsone was assessed for effects on perinatal/postnatal pup development and postnatal maternal behavior and
`function in a study in which dapsone was orally administered to female rats daily beginning on the seventh day
`of gestation and continuing until the twenty-seventh day postpartum. Maternal toxicity (decreased body weight
`and food consumption) and developmental effects (increase in stillborn pups and decreased pup weight) were
`seen at a dapsone dose of 30 mg/kg/day (approximately 560 times the systemic exposure that is associated with
`
`6 ofl0
`
`

`

`the MRHD of ACZONE Gel, 7.5%, based on AUC comparisons). No effects were observed on the viability,
`physical development, behavior, learning ability, or reproductive function of surviving pups.
`
`14
`CLINICAL STUDIES
`The safety and efficacy of once daily use of ACZONE Gel, 7.5%, was assessed in two 12-week multicenter,
`randomized, double-blind, vehicle-controlled studies. Efficacy was assessed in a total of 4340 subjects 12 years
`of age and older. The majority of the subjects had moderate acne vulgaris, 20 to 50 inflammatory and 30 to 100
`non-inflammatory lesions at baseline, who were randomized to receive either ACZONE Gel, 7.5% or vehicle.
`
`Treatment response was defined at Week 12 as the proportion of subj ects who were rated "none" or "minimal"
`with at least a two-grade improvement from baseline on the Global Acne Assessment Score (GAAS), and mean
`absolute change from baseline in both inflammatory and non-inflammatory lesion counts. A GAAS score of
`"none" corresponded to no evidence of facial acne vulgaris. A GAAS score of"minimal" corresponded to a few
`non-inflammatory lesions (comedones) being present and to a few inflammatory lesions (papules/pustules) that
`may be present.
`
`The GAAS success rate, mean reduction, and percent reduction in acne lesion counts from baseline after 12
`weeks of treatment are presented in the following table.
`
`(N=1058)
`
`21%
`
`14.3
`
`49%
`
`18.0
`
`39%
`
`30%
`
`15.6
`
`54%
`
`20.8
`
`46%
`
`Vehicle
`
`(N=l120)
`
`21%
`
`14.0
`
`48%
`
`18.7
`
`41%
`
`Table 3 Clinical Efficacy of ACZONE® Gel at Week 12 in Subjects with Acne Vulgaris
`Trial 1 Trial 2
`Vehicle
`ACZONE® Gel,
`ACZONE® Gel,
`7.5%
`7.5%
`(N=1044)
`(N=ll18)
`Global Acne Assessment Score
`GAAS Success
`30%
`(Score 0 or 1)
`Inflammatory Lesions
`Mean ab solute
`reduction
`Mean percent
`reduction
`Non-inflammatory Lesions
`Mean ab solute
`reduction
`Mean percent
`reduction
`
`16.1
`
`56%
`
`20.7
`
`45%
`
`7 ofl0
`
`

`

`HOW SUPPLIED/STORAGE AND HANDLING
`16
`ACZONE Gel is an off-white to yellow gel with suspended particles. It is supplied in an airless pump
`containing a polypropylene bottle with a high density polyethylene piston.
`
`ACZONE (dapsone) Gel, 7.5%, is supplied in the following sizes:
`
`NDC 0023-5206-30
`
`NDC 0023-5206-60
`
`NDC 0023-5206-90
`
`30 gram pump
`
`60 gram pump
`
`90 gram pump
`
`Storage: Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled
`Room Temperature]. Protect from freezing.
`
`PATIENT COUNSELING INFORMATION
`17
`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 (5.1)].
`
`¯
`
`Important Administration Instructions
`¯ Advise patients to apply ACZONE Gel, 7.5%, once daily to the entire face [see Dosage and
`Administration (2)].
`¯ ACZONE Gel, 7.5% is for topical use only.
`¯ Do not apply ACZONE Gel, 7.5% to eyes, mouth, or mucous membranes.
`
`Manufactured for: Allergan, Inc. Irvine CA 92612, U.S.A.
`By: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A.
`
`© 2016 Allergan. All rights reserved.
`Irvine, CA 92612, U.S.A.
`All trademarks are the property of their respective owners.
`Patented. See: www.allergan.com/products/patent notices
`Made in the U.S.A.
`
`.°O~O Allergan
`
`72780US 10
`
`....... Cut Here 3<2
`
`8 oflO
`
`

`

`Patient Information
`ACZONE® (AK-z6n) (dapsone) Gel, 7.5%
`Important: For use on skin only (topical use). Do not use ACZONE Gel, 7.5% in your mouth, eyes, or vagina.
`What is ACZONE Gel, 7.5%?
`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.
`
`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 ifACZONE Gel, 7.5% will 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.
`
`How do I use ACZONE Gel, 7.5%?
`¯ Use ACZONE Gel, 7.5% exactly as your doctor tells you to use it.
`¯ Apply ACZONE Gel, 7.5% one time a day.
`¯ Gently wash and pat dry the areas of your skin where you will apply ACZONE Gel, 7.5%.
`¯ Apply a pea-sized amount of ACZONE Gel, 7.5% in a thin layer to the entire face. A thin layer may also be applied to
`other affected areas as instructed by your doctor.
`¯ Rub ACZONE Gel, 7.5% in gently and completely.
`¯ Wash your hands after applying ACZONE Gel, 7.5%..
`¯
`If your acne does not get better after using ACZONE Gel, 7.5% for 12 weeks, talk to your doctor about continuing
`treatment.
`
`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:
`o back pain
`o tiredness orweakness
`o shortness of breath
`o yellow or pale skin
`o fever
`o dark brown urine
`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 68°F to 77°F (20°C to 25°C).
`¯ 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.
`
`9 oflO
`
`

`

`What are the ingredients in ACZONE Gel, 7.5%?
`Active ingredient: dapsone
`Inactive ingredients: diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate
`copolymer, isohexadecane, polysorbate 80, and purified water.
`
`Manufactured for: Allergan, Inc. Irvine CA 92612, U.S.A.
`By: DPT Laboratories, Ltd. San Antonio, "iX 78215 U.S.A.
`© 2016 Allergan.AII rights reserved.
`Irvine, CA 92612, U.S.A.
`All trademarks are the property of their respective owners.
`Patented. See: www.allergan.com/products/patent_notices
`Made in the U.S.A.
`
`oo~o Allergan
`
`For more information, call 1-800-433-8871
`This Patient Information has been approved by the U.S. Food and Drug Administration.
`
`Issued: 02/2016
`
`72780US 10
`
`10 of 10
`
`