TEMOVATE Scalp Application is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis.

This product is not recommended for use in pediatric patients under 12 years of age.

TEMOVATE Scalp Application should be applied to the affected scalp areas twice daily, once in the morning and once at night.

TEMOVATE Scalp Application is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.

TEMOVATE Scalp Application is not to 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 Scalp Application, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

TEMOVATE Scalp Application, 0.05% is supplied in plastic squeeze bottles, 25 mL {NDC 0173-0432-00) and 50 mL (NDC 0173-0432-01). Store between 4° and 25°C (39° and 77°F). Do not use near an open flame.

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

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