Cutivate-Generic, fluticasone 0.05% x 10gm cream Zoflut 0.05%

Generic Name: Fluticasone propionate
Dosage Form: cream
Fluticasone Propionate Cream, 0.05%

Rx only
For Dermatologic Use Only
Not for Ophthalmic Use.

Fluticasone Description

Fluticasone Propionate Cream, 0.05% contains Fluticasone propionate [(6α,11β,16α,17α) - 6,9, - difluoro - 11 - hydroxy - 16 - methyl - 3 - oxo - 17 - (1 - oxopropoxy)androsta - 1,4 - diene - 17 - carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Indications and Usage for Fluticasone

Fluticasone Propionate Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone Propionate 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 Fluticasone Propionate Cream in pediatric patients below 3 months of age have not been established.

Overdosage

Topically applied Fluticasone Propionate Cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Fluticasone Dosage and Administration

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

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

Other Corticosteroid-Responsive Dermatoses: Apply a thin film of Fluticasone Propionate 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.

Fluticasone Propionate Cream should not be used with occlusive dressings. Fluticasone Propionate 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 Fluticasone Propionate Cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

How is Fluticasone Supplied

Fluticasone Propionate Cream, 0.05% is supplied in:

NDC 0781-7069-27 15 g tubes

NDC 0781-7069-03 30 g tubes

NDC 0781-7069-35 60 g tubes

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

Call your doctor for medical advice about side effects.

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