Full Prescribing Information

Information for Patients (Cream)

TAZORAC® Cream (PDF)

TAZORAC®
(tazarotene) Cream, 0.05%
(tazarotene) Cream, 0.1%

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Read this carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information about the drug. This does not take the place of talks with your doctor. If you have any questions or are not sure about something, ask your doctor or pharmacist.

What is TAZORAC® Cream?

TAZORAC® (TAZ-or-ac) Cream 0.05% and 0.1% are used to treat plaque psoriasis. In addition, TAZORAC® Cream 0.1% is used to treat acne. The active ingredient is tazarotene.

Who should not use TAZORAC® Cream?

Do not use TAZORAC® Cream if

  • You are pregnant, plan to become pregnant, or may become pregnant because of the potential harm to an unborn child. Talk with your doctor about effective birth control if you are a woman who is able to become pregnant
  • You are breast feeding. We do not know if TAZORAC® Cream can pass through the milk to the baby. The potential harm to the baby is unknown
  • You have sunburn, eczema, or other continuing skin condition. If you have sunburn, wait until full recovery before using TAZORAC® Cream. TAZORAC® Cream may cause severe irritation if used on eczema
  • You are sensitive to sunlight, unless prescribed differently by your doctor
  • You take other drugs that increase your sensitivity to sunlight. These include medicines that are thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides Therefore, tell your doctor if you take any medicines. This will help your doctor decide if you can take TAZORAC® Cream
  • You are allergic to the ingredients in TAZORAC® Cream. The active ingredient is tazarotene. The inactive ingredients are benzyl alcohol, carbomer 934P, carbomer 1342, edetate disodium, medium chain triglycerides, mineral oil, purified water, sodium hydroxide, sodium thiosulfate, and sorbitan monooleate

How should I use TAZORAC® Cream 0.1% or 0.05% for treatment of psoriasis?

  • Read the directions on your prescription label carefully. Ask your doctor or pharmacist to explain anything you do not understand
  • Apply a thin film of the cream to your psoriasis areas once a day, in the evening
  • Carefully avoid application to apparently uninvolved skin. TAZORAC® Cream may be irritating to non-lesional skin
  • If you bathe or shower before using TAZORAC® Cream, be sure the skin is dry before you use TAZORAC® Cream
  • If you use a cream or lotion to soften or moisten your skin, apply TAZORAC® Cream after there is no more of the first cream or lotion on the skin
  • Wash your hands after applying the medicine, unless you are treating your hands for psoriasis. If the cream gets on areas you do not need to treat, wash it off
  • If you need to treat your hands, avoid hand contact with your eyes
  • Keep TAZORAC® Cream away from your eyes, eyelids, and mouth. If it gets in your eyes, wash them with large amounts of cool water. Contact your doctor if eye irritation continues
  • If you miss a dose, do not try to make it up. Continue with your normal schedule
  • If you are able to become pregnant, take a pregnancy test within 2 weeks prior to beginning to use TAZORAC® Cream to be sure you are not pregnant. If you have menstrual periods, begin taking TAZORAC® Cream during a normal menstrual period. These actions help assure that you are not pregnant when you begin use
  • If you become pregnant while using TAZORAC® Cream, stop use and contact your doctor right away

Do not use more TAZORAC® Cream than instructed or more often than instructed. Using larger amounts of medicine than recommended will not lead to faster or better results and may cause more side effects.

Psoriasis plaques and scales will usually begin to improve in about one to two weeks. The redness may take longer to improve. Continue to use TAZORAC® Cream as directed by your doctor. Contact your doctor if your psoriasis becomes worse.

How should I use TAZORAC® Cream 0.1% for treatment of acne?

  • If you are able to become pregnant, take a pregnancy test within 2 weeks prior to beginning to use TAZORAC® Cream to be sure you are not pregnant. If you have menstrual periods, begin taking TAZORAC® Cream during a normal menstrual period. These actions help assure that you are not pregnant when you begin use
  • If you become pregnant while using TAZORAC® Cream, stop use and contact your doctor right away
  • Read the directions on your prescription label carefully. Ask your doctor or pharmacist to explain anything you do not understand
  • Cleanse the face gently
  • After the skin is dry, apply a thin layer of TAZORAC® Cream once per day, in the evening, to the skin where acne lesions appear
  • Use enough to cover the entire affected area. In acne, the whole of the skin prone to acne should be treated
  • Follow your doctor’s directions for other routine skin care and the use of make-up. Talk to your doctor about the use of sunscreens and cosmetics
  • Wash your hands after applying the medicine. If the cream gets on areas you do not need to treat, wash it off
  • Keep TAZORAC® Cream away from your eyes, eyelids and mouth. If it gets in your eyes, wash them with large amounts of cool water. Contact your doctor if eye irritation continues
  • If you miss a dose, do not try to make it up. Continue with your normal schedule
  • Continue to use TAZORAC® Cream as directed by your doctor even though you may not begin to see improvement for at least four weeks. Contact your doctor if your acne becomes worse

What should I avoid while using TAZORAC® Cream?

  • If you are able to become pregnant, take a pregnancy test 2 weeks before beginning to use TAZORAC® Cream to be sure you are not pregnant. If you have menstrual periods, begin applying TAZORAC® Cream during a normal menstrual period. These actions help assure that you are not pregnant when you begin use
  • If you become pregnant while using TAZORAC® Cream, stop use and contact your doctor right away
  • Because of increased sensitivity to sun, avoid sunlight as much as possible while using TAZORAC® Cream. Use protective clothing and sunscreens of at least SPF 15 during the day when using TAZORAC® Cream. Also, do not use sunlamps, unless prescribed differently by your doctor
  • If you are sensitive to sunlight or in the sun a lot on your job, be especially careful to protect your skin. Use sunscreens and protective clothing. Stay out of the sun as much as possible
  • Do not cover treated areas with dressings or bandages
  • Do not use TAZORAC® Cream on skin that has eczema. TAZORAC® Cream may cause severe irritation on skin with eczema. Do not use TAZORAC® Cream until your doctor has told you that your eczema is fully recovered
  • Carefully avoid application to apparently uninvolved skin in psoriasis. TAZORAC® Cream may be more irritating to non-lesional skin. All skin involved with acne should be treated

What other precautions should I take in using TAZORAC® Cream?

Watch your reaction to TAZORAC® Cream carefully if you are also using other skin products with a strong drying effect or high amounts of alcohol, astringents, spices, lime peel, medicated soaps or shampoos, permanent wave solution, electrolysis, hair depilatories or waxes, or other products or processes that may dry or irritate the skin.

If TAZORAC® Cream is swallowed, contact your doctor or a poison control center.

If you are taking Vitamin A supplements, tell your doctor about your Vitamin A dose. TAZORAC® and Vitamin A belong to the same class of chemicals.

What are the possible side effects of TAZORAC® Cream?

For patients with psoriasis, the most common side effects of TAZORAC® Cream 0.05% and 0.1% are itching, red skin and burning or stinging.

For patients with acne, the most common side effects of TAZORAC® Cream 0.1% are peeling, dry skin, red skin, and burning.

Tell your doctor if these side effects become problems. Your doctor may wish to adjust your dose of TAZORAC® Cream. However, effectiveness of TAZORAC® Cream when used less often than once a day has not been proven.

While you take TAZORAC® Cream, weather extremes, such as wind or cold, may irritate your skin more than usual.

Storage information

Keep the tube tightly closed when not in use. Store the tube out of the reach of children, at a temperature of 77°F (25°C). Storage temperature can range from 23° to 86°F (-5° to 30°C) for short periods of time.

General advice about prescription medicines

This medicine is for your use only. Never give it to other people. It may harm them even if their skin problem appears to be the same as yours. Do not use TAZORAC® Cream for a condition for which it was not prescribed. Do not use TAZORAC® Cream after the expiration date on the bottom seal of the tube.

Where can I get more information about TAZORAC® Cream?

You can contact Allergan by calling 800-433-8871. You can ask your doctor or pharmacist for the information about TAZORAC® Cream that is written for health professionals.

Where can I get more information about psoriasis?

You can get information from:
The National Psoriasis Foundation
6600 SW 92nd Avenue, Suite 300, Portland, OR 97223-7195
Telephone (800) 723-9166, or on the World Wide Web at http://www.psoriasis.org

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ALLERGAN
Irvine, California 92612, USA    May 2004
©2004 Allergan, Inc.
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Allergan Dermatology
©2008 Allergan, Inc., Irvine, CA 92612. ® marks owned by Allergan, Inc.