DERMATOP Emollient Cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. DERMATOP Emollient Cream 0.1% may be used with caution in pediatric patients 1 year of age or older. The safety and efficacy of drug use for longer than 3 weeks in this population have not been established. Since safety and efficacy of DERMATOP Emollient Cream 0.1% have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended.

Apply a thin film of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% to the affected skin areas twice daily. Rub in gently.

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% may be used in pediatric patients 1 year of age or older. Safety and efficacy of DERMATOP Emollient cream 0.1% in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

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

DERMATOP Emollient Cream 0.1% should not be used with occlusive dressings unless directed by the physician. DERMATOP Emollient Cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is supplied in 15 g (NDC 0066-0507-15) and 60 g (NDC 0066-0507-60) tubes.

Store between 41 and 77°F (5 and 25°C).

Rx Only.

Prescribing Information as of May 2003
U.S. Patent 4,242,334

Manufactured for:
Dermik Laboratories
A Division of Aventis Pharmaceuticals Inc.
Berwyn, PA, 19312 USA

by:
Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main
Germany

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