TAZORAC Cream Ref.[27423] Active ingredients: Tazarotene

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

1.1 Plaque Psoriasis

TAZORAC (tazarotene) Cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis.

1.2 Acne Vulgaris

TAZORAC (tazarotene) Cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.

2. Dosage and Administration

2.1 Important Administration Instructions

TAZORAC Cream is for topical use only. TAZORAC Cream is not for ophthalmic, oral, or intravaginal use. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precaution (5.2)].

Wash hands thoroughly after application.

2.2 Psoriasis

It is recommended that treatment starts with TAZORAC Cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm²) of TAZORAC Cream once per day, in the evening, to cover only the psoriatic lesions. If a bath or shower is taken prior to application, the skin should be dry before applying the cream. If emollients are used, they should be applied at least an hour before application of TAZORAC Cream. Because unaffected skin may be more susceptible to irritation, application of TAZORAC Cream to these areas should be carefully avoided.

2.3 Acne

Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm²) of TAZORAC Cream 0.1% once per day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area.

Use effective sunscreens and wear protective clothing while using TAZORAC Cream [see Warnings and Precaution (5.3)].

10. Overdosage

Excessive topical use of TAZORAC Cream, 0.05% and 0.1% may lead to marked redness, peeling, or discomfort [see Warnings and Precautions (5.2)].

TAZORAC Cream, 0.05% and 0.1% are 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, the patient should be monitored, and appropriate supportive measures should be administered as necessary.

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from -5°C to 30°C (23°F to 86°F).

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