Tazarotene (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Tazarotene cream is a white cream available in concentrations of 0.05% and 0.1%. It is supplied in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene screw cap, in 30 g and 60 g sizes.

Tazarotene cream, 0.05% Tazarotene cream, 0.1%
30 g NDC 60758-556-30 NDC 60758-561-30
60 g NDC 60758-556-60 NDC 60758-561-60

Storage: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from -5°C to 30°C (23°F to 86°F).

17 PATIENT COUNSELING INFORMATION

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

Embryo f etal Toxicity

Inform females of reproductive potential of the potential risk to a fetus. Advise these patients to use effective contraception during treatment with tazarotene cream. Advise patients to inform their healthcare provider of a known or suspected pregnancy [ see Warnings and Precautions ( 5.1) and Use in Specific Populations ( 8.1, 8.3) ].

Photosensitivity and Risk of Sunburn

Advise patients to avoid excessive sun exposure and to use of sunscreens and protective measures (hat, visor). Advise patients to avoid using tazarotene cream if also taking other medicines may increase sensitivity to sunlight.

Important Administration Instructions

Advise the patient of the following:

  1. For the patient with psoriasis, apply tazarotene cream only to psoriasis skin lesions, avoiding uninvolved skin.
  2. If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides [s ee Dosage and Adminstration ( 2.1) ].
  3. Moisturizers may be used as frequently as desired.
  4. Patients with psoriasis may use a cream or lotion to soften or moisten skin at least 1 hour before applying tazarotene cream.
  5. Avoid contact with the eyes. If tazarotene cream gets in or near eyes, rinse thoroughly with water. Seek medical attention if eye irritation continues.
  6. Tazarotene cream is for topical use only. Do not apply to eyes, mouth, or other mucous membrane. Not for ophthalmic, oral, or intravaginal use.
  7. Wash hands thoroughly after applying tazarotene cream.

Distributed for Allergan
Irvine, CA 92612, U.S.A.
© 2017 Allergan. All rights reserved.
All trademarks are the property of their respective owners.Made in the U.S.A.

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P ATIENT INFORMATION Tazarotene cream, 0.05% and 0.1%
Important information: Tazarotene cream is for use on skin only. Do not use tazarotene cream in your eyes, mouth, or vagina.
What is the most important information I should know about tazarotene cream ? Tazarotene cream may cause birth defects if used during pregnancy.
  • Females must not be pregnant when they start using tazarotene cream or become pregnant during treatment with tazarotene cream .
  • For females who are able to get pregnant:○ Your doctor will order a pregnancy test for you within 2 weeks before you begin treatment with tazarotene cream to be sure that you are not pregnant. Your doctor will decide when to do the test.○ Begin treatment with tazarotene cream during a normal menstrual period.○ Use an effective form of birth control during treatment with tazarotene cream. Talk with your doctor about birth control options that may be used to prevent pregnancy during treatment with tazarotene cream. Stop using tazarotene cream and tell your doctor right away if you become pregnant while using tazarotene cream .
What is tazarotene cream ?
  • Tazarotene cream 0.05% and 0.1% is a prescription medicine used on the skin (topical) to treat people with plaque psoriasis.
  • Tazarotene cream 0.1% is also used on the skin to treat people with acne vulgaris.
  • It is not known if tazarotene cream is safe and effective for:○ the treatment of plaque psoriasis in children under 18 years of age ○ the treatment of acne vulgaris in children under 12 years of age
Who should not use tazarotene cream ? Do not use tazarotene cream if you:
  • are pregnant or plan to become pregnant. See “What is the most important information I should know about tazarotene cream?” at the beginning of this leaflet.
  • are allergic to tazarotene or any of the ingredients in tazarotene cream. See the end of this leaflet for a complete list of ingredients in tazarotene cream.
What should I tell my doctor before using tazarotene cream ? Before you use tazarotene cream , tell your doctor about all of your medical conditions, including if you:
  • have eczema or any other skin problems
  • are breastfeeding or plan to breastfeed. It is not known if tazarotene cream passes into your breast milk. Talk to your doctor about using tazarotene cream while breastfeeding.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines, vitamins, or supplements may make your skin more sensitive to sunlight. Also, tell your doctor about any cosmetics you use, including moisturizers, creams, lotions, or products that can dry out your skin.
How should I use tazarotene cream ?
  • Use tazarotene cream exactly as your doctor tells you to use it.
  • Apply tazarotene cream 1 time each day, in the evening.
  • Do not get tazarotene cream in your eyes, on your eyelids, or in your mouth. If tazarotene cream gets in or near your eyes, rinse them well with water. Call your doctor or get medical help if you have eye irritation that does not go away.
  • Wash your hands after applying tazarotene cream.
Follow these instructions for applying tazarotene cream :
  • If you have psoriasis:○ If you shower or bathe before applying tazarotene cream, your skin should be dry before applying the cream.○ You may use a cream or lotion to soften or moisten your skin at least 1 hour before you apply tazarotene cream. Apply a thin layer of tazarotene cream to cover only the psoriasis lesions.
  • If you have acne: ○ Gently wash and dry your face before applying tazarotene cream. ○ Apply a thin layer of tazarotene cream to cover only the acne lesions.
  • If you swallow tazarotene cream, call your doctor or go to the nearest hospital emergency room right away.
What should I avoid while using tazarotene cream ?
  • Avoid sunlight, including sunlamps, during treatment with tazarotene cream. Tazarotene cream can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.
  • Talk to your doctor if you get a sunburn during treatment with tazarotene cream. If you get a sunburn, do not use tazarotene cream until your sunburn is healed.
  • Avoid using cosmetics or topical medicines that may make your skin more sensitive to sunlight or make your skin dry.
  • Avoid using tazarotene cream on unaffected skin or skin with eczema because it may cause severe irritation.
What are the possible side effects of tazarotene cream ? Tazarotene cream may cause serious side effects, including:
  • Skin irritation and allergic reactions (hypersensitivity). Tazarotene cream may cause increased skin irritation and hives. Tell your doctor if you develop hives, or itching, burning, redness, or peeling of your skin during treatment with tazarotene cream. If you develop hives or skin irritation, your doctor may tell you to stop using tazarotene cream until your skin heals, tell you to use tazarotene cream less often, or change your tazarotene cream dose. Also, wind or cold weather may be more irritating to your skin while you are using tazarotene cream.
  • Sensitivity to sunlight and risk of sunburn. See “What should I avoid while using tazarotene cream?”
The most common side effects of tazarotene cream in people with psoriasis include itching, redness and burning.The most common side effects of tazarotene cream in people with acne include peeling, dry skin, redness and burning.These are not all the possible side effects of tazarotene cream. 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 tazarotene cream ?
  • Store tazarotene cream at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep tazarotene cream and all medicines out of the reach of children.
General information about the safe and effective use of tazarotene cream . Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tazarotene cream for a condition for which it was not prescribed. Do not give tazarotene cream 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 tazarotene cream that is written for health professionals.
What are the ingredients in tazarotene cream ? Active ingredient: tazaroteneInactive ingredients: benzyl alcohol 1%, carbomer 1342, carbomer homopolymer type B, edetate disodium, medium chain triglycerides, mineral oil, purified water, sodium hydroxide, sodium thiosulfate, and sorbitan monooleateDistributed for AllerganIrvine, CA 92612, U.S.A.© 2017 Allergan. All rights reserved.All trademarks are the property of their respective owners.Made in the U.S.A.Pacific PharmaFor more information call 1-800-678-1605.

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: November/2017

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