Drug Catalog - Product Detail
FLUTICASONE PROPIONATE OINTMENT OINT 0.0005 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0221-37 | PADAGIS | 60 | 0.005% | OINTMENT |
PACKAGE FILES
Generic Name
FLUTICASONE PROPIONATE
Substance Name
FLUTICASONE PROPIONATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA076668
Description
11 DESCRIPTION Fluticasone Propionate Ointment, 0.005% contains fluticasone propionate [ S -Fluoromethyl 6α, 9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate], a synthetic fluorinated corticosteroid, for topical use. Chemically, fluticasone propionate is C 25 H 31 F 3 O 5 S. It has the following structural formula: 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 a white to off-white translucent ointment base of liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleate. Structural Formula Image
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone Propionate Ointment, 0.005% is a white to off-white translucent ointment supplied as follows: 15 g tube (NDC 45802- 221 -35) 30 g tube (NDC 45802- 221 -11) 60 g tube (NDC 45802- 221 -37) Store at 20-25°C (68-77°F)
Indications & Usage
1 INDICATIONS AND USAGE Fluticasone propionate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. Fluticasone propionate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply a thin film of fluticasone propionate ointment to the affected skin areas twice daily. Rub in gently. Avoid use with occlusive dressing. Fluticasone propionate ointment is for topical use only; it is not for ophthalmic, oral, or intravaginal use. Apply a thin film to affected skin areas twice daily. ( 2 ) Not for ophthalmic, oral or intravaginal use. ( 2 )