Fabior

FABIOR® (tazarotene) Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

• Stiefel Laboratories, Inc.

Serious side effects have been reported with Fabior.

Common side effects of Fabior include the following:

• itching
• dry skin
• burning/stinging
• red skin
• skin irritation
• skin pain
• peeling or flaking of the skin

This is not a complete list of Fabior side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tazarotene is a compound similar to vitamin A. It helps the skin to renew itself more quickly and may improve the appearance and texture of skin.

The Avage brand of tazarotene cream is used to reduce the appearance of fine wrinkles on the face, mottled light and dark skin patches on the face, and benign facial lentigines (non-cancerous freckles) in adults and adolescents who are at least 17 years old.

The Fabior and Tazorac brands of tazarotene topical are used to treat acne vulgaris in adults and adolescents who are at least 12 years old.

Tazorac is also used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults.

Tazarotene topical may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using tazarotene topical and call your doctor at once if you have:

• severe skin irritation (burning, stinging, itching) after applying the medicine;

• severe redness or discomfort; or

• swelling, warmth, oozing, or other signs of skin infection.

Common side effects may include:

• dry, scaly, or peeling skin;

• skin redness or burning; or

• itching or other irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Fabior by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Do not put in the vagina.
• If you get this medicine in any of these areas, rinse well with water.
• If you are able to get pregnant, start using Fabior (tazarotene foam) during your normal menstrual period.
• Wash your hands before use.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on cuts, scrapes, eczema, or damaged skin.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• Some products are to be used at bedtime. For some products it does not matter. Check with the pharmacist about how to use this medicine.
• Practice good skin care and avoid the sun.
• Avoid putting on healthy skin.
• Shake well before use.
• Wash your hands after use.
• This medicine may catch on fire. Do not use near an open flame or while smoking.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stinging.
• Dry skin.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Do not freeze.
• Store upright with the cap on.
• Protect from heat and sunlight. Do not puncture or burn even if it seems empty.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction to Fabior foam: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Fabior and call your doctor at once if you have:

• severe skin irritation (burning, stinging, itching) after applying the medicine;

• severe redness or discomfort; or

• swelling, warmth, oozing, or other signs of skin infection.

Common Fabior side effects may include:

• dry, scaly, or peeling skin;

• skin redness or burning; or

• itching or other irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.