Drug Catalog - Product Detail
MOMETASONE FUR 0.1% OINT 45GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0225-55 | GLENMARK PHARMACEUTICALS | 45 | 0.1% | OINTMENT |
PACKAGE FILES
Generic Name
MOMETASONE FUROATE
Substance Name
MOMETASONE FUROATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA078571
Description
11 DESCRIPTION Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.43 and the following structural formula: Mometasone furoate, USP is a white or almost white powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, slightly soluble in alcohol. Each gram of mometasone furoate Ointment USP, 0.1% contains: 1 mg mometasone furoate, USP in an ointment base of hexylene glycol, phosphoric acid, propylene glycol monopalmitostearate, purified water, white petrolatum, and white wax. mometasone-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Mometasone Furoate Ointment USP, 0.1% is a translucent white soft, uniform and smooth ointment and is supplied in 15 gram (NDC 68462-225-17) and 45 gram (NDC 68462-225-55) tubes; boxes of one. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not refrigerate and avoid freezing.
Indications & Usage
1 INDICATIONS AND USAGE Mometasone furoate ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone furoate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥2 years of age. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply a thin film of mometasone furoate ointment to the affected skin areas once daily. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1)] . Do not use mometasone furoate Ointment with occlusive dressings unless directed by a physician. Do not apply mometasone furoate Ointment in the diaper area, as diapers or plastic pants constitute occlusive dressing. Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application. Mometasone furoate Ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use. • Apply a thin film to the affected skin areas once daily. ( 2 ) • Discontinue therapy when control is achieved. ( 2 ) • If no improvement is seen within 2 weeks, reassess diagnosis. ( 2 ) • Do not use with occlusive dressings unless directed by a physician. ( 2 )