TEMOVATE Cream and Ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Apply a thin layer of TEMOVATE Cream or Ointment to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS).

TEMOVATE Cream and Ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

TEMOVATE Cream and Ointment should not be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with TEMOVATE Cream or Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

TEMOVATE Cream, 0.05% is supplied in 15-g (NDC 0173-0375-73), 30-g (NDC 0173-0375-72), 45-g (NDC 0173-0375-01), and 60-g (NDC 0173-0375-02) tubes.

TEMOVATE Ointment, 0.05% is supplied in 15-g (NDC 0173-0376-73), 30-g (NDC 0173-0376-72), 45-g (NDC 0173-0376-01), and 60-g (NDC 0173-0376-02) tubes.

Store Between 15° and 30°C (59° and 86°F). TEMOVATE Cream should not be refrigerated.

Glaxo Wellcome Inc. Research Triangle Park, NC 27709. July 2000. FDA Rev date: 4/2/2003

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