Tazarotene Cream

• If you have an allergy to tazarotene, vitamin A, or any other part of tazarotene cream.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you are able to get pregnant and are not using birth control.
• If you are sunburned.
• If you are taking any drugs that may make your skin more sensitive to light. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with tazarotene cream.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Skin irritation.
• Itching.
• Burning.
• Redness.
• Peeling.
• Sunburn.
• Swelling.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Assessment Prior to Treatment Initiation

Obtain a pregnancy test within 2 weeks prior to Tazarotene Cream therapy. Initiate Tazarotene Cream therapy during a menstrual period [see Contraindications (4.1), Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)].

Carefully assess facial pigmented lesions of concern by a qualified physician (e.g., dermatologist) before application of Tazarotene Cream [see Warnings and Precautions (5.4)].

Dosage and Administration Instructions

Remove any makeup before applying Tazarotene Cream to the face. Dry the skin before applying the cream after face washing, bathing, or showering. Apply a pea-sized amount once a day at bedtime to lightly cover the entire face, including the eyelids, if desired. Avoid accidental transfer of Tazarotene Cream into eyes. Facial moisturizers may be used as frequently as desired. Emollients or moisturizers can be applied either before or after applying Tazarotene Cream. However, ensure that the first cream or lotion has absorbed into the skin and has dried completely before subsequent cream or lotion application.

If contact with eyes occurs, rinse thoroughly with water.

Tazarotene Cream is for topical use only. Tazarotene Cream is not for ophthalmic, oral, or intravaginal use.

Use effective sunscreens and wear protective clothing while using Tazarotene Cream.

Cream: 1 mg of tazarotene per gram (0.1%) of white cream in 30 gram tubes.

Tazarotene Cream is not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, monitor the patient closely and administer appropriate supportive measures, as necessary.