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Clearer Skin in TWELVE WEEKS Individual Results May Vary READY F GET OR clearer skin IN TWELVE WEEKS Individual results may vary. Not an actual patient. Approved Uses TAZORAC® (tazarotene) Cream 0.1% is used to treat acne. TAZORAC® (tazarotene) Gel 0.1% is used to treat people with mild to moderate facial acne vulgaris. IMPORTANT SAFETY INFORMATION WARNINGS Retinoids may cause fetal harm when administered to a pregnant female. Do not use TAZORAC Cream and Gel if you are pregnant, attempting to become pregnant or at high risk of pregnancy. Consult your physician for adequate birth control measures if you are a female of child-bearing potential. To help assure that you are not pregnant when you begin use, your doctor will need to perform a pregnancy test within 2 weeks prior to starting use of TAZORAC Cream or Gel and/or begin taking TAZORAC Cream or Gel during a normal menstrual period. To report an adverse event, side effect, or product complaint, call or email: Phone: 1-866-665-2782; Fax: 510-595-8183; Email: [email protected]. Please see additional Important Safety Information on next page. Time for TAZORAC® (tazarotene) cream and gel 0.1%! Set TAZORAC where you’ll see 3 steps to clearer skin: it every night and remember: 1. CLEANSE More doesn’t mean better. Gently wash face with warm water and a mild You don’t need a ton of TAZORAC for it to work, and cleanser, then pat skin dry. using more won’t give you clearer skin any faster—it may just irritate your skin. 2. MOISTURIZE Apply a moisturizer before TAZORAC. Moisturizing is a key step before applying 3. TREAT TAZORAC, so don’t forget it or skip it! Spread 1 pea-sized drop, once a day in the It may seem weird to use a moisturizer if your face is evening, over the affected areas of the face. Avoid naturally oily, but dermatologists agree even oily skin eyes, eyelids, and mouth. Wash hands thoroughly. needs to be moisturized. IMPORTANT SAFETY INFORMATION (continued) WARNINGS (continued) TAZORAC Cream and Gel 0.1% should not be used if you are allergic to any of its ingredients. Please see complete Information for Patients for a list of ingredients. PRECAUTIONS TAZORAC Cream and Gel should not be used if you are also taking other drugs that increase your sensitivity to sunlight (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides). Inform your physician if you are taking any other medications. Use protective clothing and sunscreens of at least SPF 15 during the day when using TAZORAC Cream and Gel. Do not use TAZORAC Cream and Gel if you have sunburn, eczema, or other continuing skin condition. Use TAZORAC Cream and Gel with caution if you are using other topical products that might dry or irritate the skin. Please see additional Important Safety Information on next page. Clearer skin is possible as early as 4 weeks StickTolerability to your new skinTolerability care routine and youTolerability may notice an improvementTolerability in just 4 weeks, with full results at 12 weeks Baseline Week 12 Baseline Week 12 Actual, unretouched photos of TAZORAC® (tazarotene) Cream and Gel 0.1% patients from clinical trials. In clinical trials, TAZORAC improved acne with 12 weeks of use. Actual results may vary. IMPORTANT SAFETY INFORMATION (continued) ADVERSE REACTIONS TAZORAC Cream and Gel 0.1% may cause serious side effects, including: • Skin irritation and allergic reactions (hypersensitivity). Tell your doctor if you develop hives, or itching, burning, redness, or peeling of your skin during treatment. Please see full Prescribing Information and Patient Information. LEARER SKIN 2. Place TAZORAC® (tazarotene) C Cream or Gel 0.1% where you won’t miss it. Don’t let your busy schedule get in the way of treating is coming your acne. Keep the medication ! where you’ll remember to use it IN TWELVE WEEKS every night. Individual results may vary. 3. Remind yourself. Set a reminder 3 things to remember: on your phone or ask your parents to help you remember to use 1. Take selfies every week. Progress pics will help you and TAZORAC every single night. your doctor see how far you’ve come. Questions or concerns about treatment? Call your doctor. He or she wants you to succeed as much as you do. IMPORTANT SAFETY INFORMATION WARNINGS Retinoids may cause fetal harm when administered to a pregnant female. Do not use TAZORAC Cream and Gel if you are pregnant, attempting to become pregnant or at high risk of pregnancy. Consult your physician for adequate birth control measures if you are a female of child-bearing potential. To help assure that you are not pregnant when you begin use, your doctor will need to perform a pregnancy test within 2 weeks prior to starting use of TAZORAC Cream or Gel and/or begin taking TAZORAC Cream or Gel during a normal menstrual period. Please see full Prescribing Information and Patient Information. TAZORAC® is a registered trademark of Almirall, LLC. © Almirall, LLC. Exton, PA 19341. www.almirall.us. All rights reserved. US-TAZ-2000018 04-2020 HIGHLIGHTS OF PRESCRIBING INFORMATION ---------------------------- WARNINGS AND PRECAUTIONS --------------------------- These highlights do not include all the information needed to use TAZORAC® Gel • Embryofetal Toxicity: TAZORAC Gel contains tazarotene, which is a teratogen. safely and effectively. See full prescribing information for TAZORAC® Gel. TAZORAC Gel is contraindicated in pregnancy. Females of child-bearing potential TAZORAC® (tazarotene) gel, 0.05% and 0.1%, for topical use should have a negative pregnancy test within 2 weeks prior to initiating treatment and Initial U.S. Approval: 1997 use an effective method of contraception during treatment. (5.1) ------------------------------- INDICATIONS AND USAGE ------------------------------ • Local Irritation: Excessive pruritus, burning, skin redness or peeling can occur. If these reactions occur, discontinue until the integrity of the skin has been restored, or • TAZORAC® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of consider reducing dosing frequency or in the case of psoriasis, consider switching to plaque psoriasis of up to 20% body surface area involvement. (1.1) the lower concentration. TAZORAC Gel should not be used on eczematous skin, as it • TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial may cause severe irritation. (5.2) acne vulgaris. (1.2) • Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and Limitations of Use weather extremes. Wear sunscreen daily. TAZORAC Gel should be administered with caution if the patient is also taking drugs known to be photosensitizers. (5.3) • The safety of TAZORAC Gel use on more than 20% body surface area has not been established. (1.3) --------------------------------- ADVERSE REACTIONS -------------------------------- ---------------------------- DOSAGE AND ADMINISTRATION --------------------------- • Plaque Psoriasis: Most common adverse reactions occurring in 10 to 30% of patients are pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin • Apply a thin layer of TAZORAC Gel only to the affected area once daily in the evening. pain. (6.1) (2.1, 2.2) • Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are • Not for ophthalmic, oral, or intravaginal use. (2.2) desquamation, burning/stinging, dry skin, erythema and pruritus. (6.1) • If contact with eyes occurs, rinse thoroughly with water. (2.2) To report SUSPECTED ADVERSE REACTIONS, contact Allergan, Inc. at 1-800-678-1605 or --------------------------- DOSAGE FORMS AND STRENGTHS ------------------------- FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Gel, 0.05% and 0.1% (3) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. --------------------------------- CONTRAINDICATIONS -------------------------------- Revised: 08/2019 • Pregnancy (4, 8.1) • Hypersensitivity (4) FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN SPECIFIC POPULATIONS 1 INDICATIONS AND USAGE 8.1 Pregnancy 1.1 Plaque Psoriasis 8.2 Lactation 1.2 Acne Vulgaris 8.3 Females and Males of Reproductive Potential 1.3 Limitations of Use 8.4 Pediatric Use 2 DOSAGE AND ADMINISTRATION 8.5 Geriatric Use 2.1 Psoriasis 10 OVERDOSAGE 2.2 Acne 11 DESCRIPTION 3 DOSAGE FORMS AND STRENGTHS 12 CLINICAL PHARMACOLOGY 4 CONTRAINDICATIONS 12.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 12.2 Pharmacodynamics 5.1 Embryofetal Toxicity 12.3 Pharmacokinetics 5.2 Local Irritation and Hypersensitivity Reactions 13 NONCLINICAL TOXICOLOGY 5.3 Photosensitivity and Risk for Sunburn 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 6 ADVERSE REACTIONS 14 CLINICAL STUDIES 6.1 Clinical Trials Experience 16 HOW SUPPLIED/STORAGE AND HANDLING 6.2 Postmarketing Experience 17 PATIENT COUNSELING INFORMATION 7 DRUG INTERACTIONS * Sections or subsections omitted from the full prescribing information are not listed. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Plaque Psoriasis TAZORAC® (tazarotene) Gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.2 Acne Vulgaris TAZORAC (tazarotene) Gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. The efficacy of TAZORAC Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. 1.3 Limitations of Use The safety of TAZORAC Gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. 2 DOSAGE AND ADMINISTRATION TAZORAC Gel is for topical use only. TAZORAC Gel is not for ophthalmic, oral, or intravaginal use. Avoid accidental transfer of TAZORAC Gel into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precautions (5.2)]. Wash hands thoroughly after application. 2.1 Psoriasis It is recommended that treatment starts with TAZORAC Gel, 0.05%, with strength increased to 0.1% if tolerated and medically indicated.
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