TAZORAC® (tazarotene) Gel 0.05% and 0.1% are indicated for the topical treatment of patients with stable plaque psoriasis of up to 20% body surface area involvement.

TAZORAC® (tazarotene) Gel 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.

The efficacy of TAZORAC® Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.

General: Application may cause excessive irritation in the skin of certain sensitive individuals. In cases where it has been necessary to temporarily discontinue therapy, or the dosing has been reduced to a lower concentration (in patients with psoriasis) or to an interval the patient can tolerate, therapy can be resumed, or the drug concentration or frequency of application can be increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once-daily dosing frequencies.

For Psoriasis: It is recommended that treatment start with TAZORAC® 0.05% Gel, with strength increased to 0.1% if tolerated and medically indicated. Apply TAZORAC® Gel once a day, in the evening, to psoriatic lesions, using enough (2 mg/cm² ) to cover only the lesion with a thin film to no more than 20% of body surface area. If a bath or shower is taken prior to application, the skin should be dry before applying the gel. If emollients are used, they should be applied at least an hour before application of TAZORAC® Gel. Because unaffected skin may be more susceptible to irritation, application of tazarotene to these areas should be carefully avoided. TAZORAC® Gel was investigated for up to 12 months during clinical trials for psoriasis.

For Acne: Cleanse the face gently. After the skin is dry, apply a thin film of TAZORAC® Gel 0.1% (2 mg/cm² ) once a day, in the evening, to the skin where acne lesions appear. Use enough to cover the entire affected area. TAZORAC® Gel was investigated for up to 12 weeks during clinical trials for acne.

TAZORAC® (tazarotene) Gel is available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30-gm and 100-gm sizes.

NOTE: TAZORAC®(tarzarotene) Gel should be stored at 25°C (77°F): excursion permitted to 15-30°C (59-86°F).

ALLERGAN, Irvine, California 92612, USA January 2004. FDA rev date: 12/2/2003

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