"The US Food and Drug Administration (FDA) has approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar, Leo Pharma Inc) for topical treatment of plaque psoriasis in adults 18 years of age and older, according to a "...
Important information: TAZORAC® Cream is for use on skin only. Do not use TAZORAC® Cream in your eyes, mouth, or vagina.
What is the most important information I should know about TAZORAC® Cream?
TAZORAC® Cream may cause birth defects if used during pregnancy.
- Females must not be pregnant when they start using TAZORAC® Cream or become pregnant during treatment with TAZORAC® Cream.
- For females who are able to get
- Your doctor should order a pregnancy test for you within 2 weeks before you begin treatment with TAZORAC® Cream to be sure that you are not pregnant. Your doctor will decide when to do the test.
- You should begin treatment with TAZORAC® Cream during a normal menstrual period.
- Use an effective form of birth control during treatment with TAZORAC® Cream. Talk with your doctor about birth control options that may be used to prevent pregnancy during treatment with TAZORAC® Cream.
- Stop using TAZORAC® Cream and tell your doctor right away if you become pregnant while using TAZORAC® Cream.
What is TAZORAC® Cream?
- TAZORAC® Cream 0.05% and 0.1% is a prescription medicine used on the skin (topical) to treat people with plaque psoriasis.
- TAZORAC® Cream 0.1% is also used on the skin to treat people with acne vulgaris.
It is not known if TAZORAC® Cream is safe and effective for treating psoriasis in children under 18 years of age, or for treating acne vulgaris in children under 12 years of age.
Who should not use TAZORAC® Cream?
Do not use TAZORAC® Cream if you:
- are pregnant, or you are able to become pregnant and are not using effective birth control. See the section called “What is the most important information I should know about TAZORAC® Cream?” at the beginning of this leaflet.
- are allergic to any of the ingredients in TAZORAC® Cream. See the end of this leaflet for a complete list of ingredients in TAZORAC® Cream.
What should I tell my doctor before using TAZORAC® Cream?
Before you use TAZORAC® Cream, tell your doctor if you:
- have eczema or any other skin problems
- have any other medical conditions
- are breastfeeding or plan to breastfeed. It is not known if TAZORAC® Cream passes into your breast milk. You and your doctor should decide if you will use TAZORAC® Cream 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. 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 TAZORAC® Cream?
- Use TAZORAC® Cream exactly as your doctor tells you to use it.
- If you have psoriasis:
- If you shower or bathe before applying TAZORAC® 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 TAZORAC® Cream.
- Apply a thin layer of TAZORAC® Cream to cover only the psoriasis lesions, 1 time each day, in the evening.
- If you have acne:
- Gently wash and dry your face before applying TAZORAC® Cream.
- Apply a thin layer of TAZORAC® Cream to cover all of the affected skin areas, 1 time each day, in the evening.
- TAZORAC® Cream should not be applied to unaffected skin. TAZORAC® Cream may cause irritation to unaffected skin.
- TAZORAC® Cream should not be used on skin with eczema because it may cause severe irritation.
- Do not get TAZORAC® Cream in your eyes, on your eyelids, or in your mouth. If TAZORAC®
- Cream gets in or near your eyes, rinse them well with water.
- Wash your hands after applying TAZORAC® Cream.
- If you swallow TAZORAC® Cream, call your doctor or go to the nearest hospital emergency room right away.
What should I avoid while using TAZORAC® Cream?
- Avoid sunlight, including sunlamps, as much as possible.
TAZORAC® Cream can make your skin more sensitive to the sun, and the
light from sunlamps and tanning beds. You could get a severe sunburn. Use
sunscreen with at least SPF 15, 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 TAZORAC® Cream. If you get a sunburn, do not use TAZORAC® Cream until your sunburn is healed.
What are the possible side effects of TAZORAC® Cream?
TAZORAC® Cream may cause serious side effects, including:
- Skin irritation. TAZORAC® Cream may cause itching, burning, redness, and peeling of your skin. Also, wind or cold weather may be more irritating to your skin while you are using TAZORAC® Cream. Tell your doctor if you develop any of these symptoms of skin irritation with TAZORAC® Cream. Your doctor may tell you to stop using TAZORAC® Cream until your skin heals, change your dose of TAZORAC® Cream, or your doctor may tell you to use it less often, if you get too much skin irritation.
The most common side effects of TAZORAC® Cream in people with plaque psoriasis include:
The most common side effects of TAZORAC® Cream in people with acne include:
- dry skin
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of TAZORAC® Cream. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store TAZORAC® Cream?
- Store TAZORAC® Cream at room temperature between 68°F to 77°F (20°C to 25°C).
Keep TAZORAC® Cream and all medicines out of the reach of children.
General information about the safe and effective use of TAZORAC® Cream.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TAZORAC® Cream for a condition for which it was not prescribed. Do not give TAZORAC® Cream to other people, even if they have the same symptoms you have. It may harm them.
If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about TAZORAC® Cream that is written for health professionals.
For more information call 1-800-433-8871 or go to www.tazorac.com.
What are the ingredients in TAZORAC® Cream?
Active ingredient: tazarotene
Inactive 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 monooleate
Last reviewed on RxList: 1/22/2014
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
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