Drug Catalog - Product Detail
FLUTICASONE PROPIONATE LOTION LOT 0.0005 60ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0427-02 | GLENMARK PHARMACEUTICALS | 60 | 0.05% | LOTION |
PACKAGE FILES
Generic Name
FLUTICASONE PROPIONATE
Substance Name
FLUTICASONE PROPIONATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA090759
Description
11 DESCRIPTION Fluticasone propionate lotion USP, 0.05% contains fluticasone propionate USP 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. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate USP is C 25 H 31 F 3 O 5 S. It has the following structural formula: Fluticasone propionate USP is a white or almost white powder with a molecular weight of 500.6 g/mol. It is freely soluble in dimethylformamide; slightly soluble in alcohol; sparingly soluble in acetone and in dichloromethane; insoluble in water. Each gram of fluticasone propionate lotion USP contains 0.5 mg fluticasone propionate USP in a base of cetostearyl alcohol, polyoxyl 20 cetostearyl ether, citric acid anhydrous, dimethicone 360, isopropyl myristate, light mineral oil, propylene glycol, sodium citrate anhydrous, sorbitan monostearate, and purified water, with imidurea, methylparaben, and propylparaben as preservatives. chemical-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone propionate lotion USP, 0.05% is a white translucent smooth homogeneous lotion supplied in HDPE and PP bottles as follows: 60 mL bottles: (NDC 68462-427-02) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Keep container tightly sealed.
Indications & Usage
1 INDICATIONS AND USAGE Fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older. Fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 year of age and older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply a thin film of fluticasone propionate lotion to the affected skin areas once daily. Rub in gently. Discontinue use when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. The safety and efficacy of fluticasone propionate lotion have not been established beyond 4 weeks of use. Avoid use with occlusive dressings or application to the diaper area [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) and ( Error! Hyperlink reference not valid. ) ]. Fluticasone propionate lotion is for topical use only, and not for ophthalmic, oral, or intravaginal use. • Apply a thin film to the affected skin areas once daily. Rub in gently. ( Error! Hyperlink reference not valid. ) • Discontinue use when control is achieved. ( Error! Hyperlink reference not valid. ) • Reassess diagnosis if no improvement in 2 weeks. ( Error! Hyperlink reference not valid. ) • The safety and efficacy of fluticasone propionate lotion have not been established beyond four weeks of use. ( Error! Hyperlink reference not valid. ) • Avoid use under occlusion or application to diaper area. ( Error! Hyperlink reference not valid. ) • Not for ophthalmic, oral, or intravaginal use. ( Error! Hyperlink reference not valid. )