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

Generic Name: fluticasone propionate
Dosage Form: ointment

Rx Only

For Dermatologic Use Only—Not for Ophthalmic Use.

Fluticasone Ointment Description

Fluticasone Propionate Ointment 0.005% 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.

Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water.

Each gram of fluticasone propionate ointment contains fluticasone propionate 0.05 mg in an ointment base of mineral oil, microcrystalline wax, sorbitan sesquioleate and propylene glycol.

Indications and Usage for Fluticasone Ointment

Fluticasone propionate ointment is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.

Overdosage

Topically applied fluticasone propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS section).

Fluticasone Ointment Dosage and Administration

Apply a thin film of fluticasone propionate ointment to the affected skin areas twice daily. Rub in gently.

Fluticasone propionate ointment should not be used with occlusive dressings.

Geriatric Use

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

How is Fluticasone Ointment Supplied

Fluticasone Propionate Ointment, 0.005% is supplied in:
5 g tubes (physician samples, tubes only) NDC 51672-4095-5
15 g tubes NDC 51672-4095-1
30 g tubes NDC 51672-4095-2
60 g tubes NDC 51672-4095-3

Store between 20° and 25°C (68° and 77°F).
[see USP Controlled Room Temperature].

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