CUTIVATE Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE Cream in pediatric patients below 3 months of age have not been established.

CUTIVATE Cream may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of CUTIVATE Cream in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS : Pediatric Use ). The safety and efficacy of CUTIVATE Cream in pediatric patients below 3 months of age have not been established.

Atopic Dermatitis:   Apply a thin film of CUTIVATE Cream to the affected skin areas once or twice daily. Rub in gently.

Other Corticosteroid-Responsive Dermatoses:   Apply a thin film of CUTIVATE Cream to the affected skin areas twice daily. Rub in gently.

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

CUTIVATE Cream should not be used with occlusive dressings. CUTIVATE Cream should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

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

CUTIVATE Cream is supplied in:

15-g tubes (NDC 0173-0430-00)

30-g tubes (NDC 0173-0430-01)

60-g tubes (NDC 0173-0430-02)

Store between 2° and 30°C (36° and 86°F).

Glaxo Wellcome Inc., Research Triangle Park, NC 27709

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