What is Tazorac?
- Tazorac Gel 0.05% and 0.1% is a prescription medicine used on the skin (topical) to treat people with stable plaque psoriasis on up to 20% of your body surface.
- Tazorac Gel 0.1% is also used on the skin to treat people with mild to moderate facial acne vulgaris.
It is not known if Tazorac Gel is:
- safe and effective for use in children under 12 years of age.
- effective for the treatment of acne in people who have been treated with retinoid medicines or have acne that does not respond to treatment with oral antibiotics.
- safe if used over more than 20% of your body for the treatment of psoriasis or acne.
What is the most important information I should know about Tazorac?
Important information: Tazorac Gel is for use on skin only. Do not use Tazorac Gel in your eyes, mouth, or vagina.
Tazorac Gel may cause birth defects if used during pregnancy.
- Females must not be pregnant when they start using Tazorac Gel or become pregnant during treatment with Tazorac Gel.
- For females who can become pregnant:
- Your doctor will order a pregnancy test for you within 2 weeks before you begin treatment with Tazorac Gel to be sure that you are not pregnant. Your doctor will decide when to do the test.
- Begin treatment with Tazorac Gel during a normal menstrual period.
- Use an effective form of birth control during treatment with Tazorac Gel. Talk with your doctor about birth control options that may be used to prevent pregnancy during treatment with Tazorac Gel.
- Stop using Tazorac Gel and tell your doctor right away if you become pregnant while using Tazorac Gel.
Who should not use Tazorac?
Do not use Tazorac Gel if you:
- are pregnant or plan to become pregnant. See “What is the most important information I should know about Tazorac Gel?” at the beginning of this leaflet.
- are allergic to tazarotene or any of the ingredients in Tazorac Gel. See the end of this guide for a complete list of ingredients in Tazorac Gel.
What should I tell my healthcare provider before using Tazorac?
Before you use Tazorac Gel, 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 Tazorac Gel passes into your breast milk. Talk to your doctor about using Tazorac Gel 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.
Keep a list of your medicines to show to your doctor and pharmacist when you get a new medicine.
How should I use Tazorac?
- Use Tazorac Gel exactly as your doctor tells you to use it.
- Apply Tazorac Gel 1 time each day, in the evening.
- Do not get Tazorac Gel in your eyes, on your eyelids, or in your mouth. If Tazorac Gel 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 Tazorac Gel.
Follow these instructions for applying Tazorac Gel:
- If you have psoriasis:
- If you shower or bathe before applying Tazorac Gel, your skin should be dry before applying the gel.
- You may use a cream or lotion to soften or moisten your skin at least 1 hour before you apply Tazorac Gel.
- Apply a thin layer of Tazorac Gel to cover only the psoriasis lesions.
- If you have acne:
- Gently wash and dry your face before applying Tazorac Gel.
- Apply a thin layer of Tazorac Gel to cover only the acne lesions.
- If you swallow Tazorac Gel, call your doctor or go to the nearest hospital emergency room right away.
- Avoid sunlight, including sunlamps, during treatment with Tazorac Gel. Tazorac Gel 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 Tazorac Gel. If you get a sunburn, do not use Tazorac Gel 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 Tazorac Gel on unaffected skin or skin with eczema because it may cause severe irritation.
What are the possible side effects of Tazorac?
Tazorac Gel may cause serious side effects, including:
- Skin irritation and allergic reactions (hypersensitivity). Tazorac Gel may cause increased skin irritation (including blistering and skin peeling) and allergic reactions (including hives). Tell your doctor if you develop itching, burning, redness, blistering or peeling of your skin during treatment with Tazorac Gel. If you develop skin irritation or hives, your doctor may tell you to temporarily stop using Tazorac Gel until your skin heals, tell you to use Tazorac Gel less often, or change your Tazorac Gel dose. Also, wind or cold weather may be more irritating to your skin while you are using Tazorac Gel.
- Sensitivity to sunlight and risk of sunburn. See “What should I avoid while using Tazorac Gel?”
The most common side effects of Tazorac Gel in people with plaque psoriasis include itching, burning, redness, worsening of psoriasis, irritation and skin pain.
The most common side effects of Tazorac Gel in people with acne include peeling, burning, dry skin, redness and itching.
These are not all the possible side effects of Tazorac Gel. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Tazorac
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tazorac Gel for a condition for which it was not prescribed. Do not give Tazorac Gel 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 Tazorac Gel that is written for health professionals.
How should I store Tazorac?
- Store Tazorac Gel at 68°F to 77°F (20°C to 25°C).
- Keep Tazorac Gel and all medicines out of the reach of children.
What are the ingredients in Tazorac?
Active ingredient: tazarotene
Inactive ingredients: ascorbic acid, benzyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, carbomer homopolymer type B, edetate disodium, hexylene glycol, poloxamer 407, polyethylene glycol 400, polysorbate 40, purified water, and tromethamine
For more information, call 1-800-678-1605 or go to www.tazorac.com