Drug Catalog - Product Detail
MOMETASONE FUROATE OINTMENT OINT 0.001 15GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0119-37 | PADAGIS | 15 | 0.1% | OINTMENT |
PACKAGE FILES
Generic Name
MOMETASONE FUROATE
Substance Name
MOMETASONE FUROATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA076067
Description
11 DESCRIPTION Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate 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 521.4 and the following structural formula: Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone Furoate Ointment USP, 0.1% contains 1 mg mometasone furoate in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax and white petrolatum. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Mometasone Furoate Ointment USP, 0.1% is a white to off-white uniform ointment and supplied in 15-gram (NDC 45802- 119 -37) and 45-gram (NDC 45802- 119 -42) tubes; boxes of one. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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, 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 ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply a thin film of Mometasone Furoate Ointment, 0.1% 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, 0.1% with occlusive dressings unless directed by a physician. Do not apply Mometasone Furoate Ointment, 0.1% 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, 0.1% 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 )