Drug Catalog - Product Detail
METRONIDAZOLE TOPICAL GEL 1% 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 66993-0936-61 | PRASCO LABORATORIES | 60 | 1% | GEL |
PACKAGE FILES
Generic Name
METRONIDAZOLE
Substance Name
METRONIDAZOLE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA021789
Description
11 DESCRIPTION Metronidazole Gel, 1% is a nitromidazole for topical use. Metronidazole Gel, 1% is a clear, colorless to pale yellow, aqueous gel. Each gram contains 10 mg of metronidazole. Chemically, metronidazole is 2-methyl-5-nitro-1 H- imidazole-1-ethanol. The molecular formula for metronidazole is C 6 H 9 N 3 O 3 . It has the following structural formula: Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20˚C. Metronidazole belongs to the nitroimidazole class of compounds. The inactive ingredients are betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water. Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Metronidazole Gel, 1% is clear, colorless to pale yellow in color, and supplied as follows: 60 gram tube – NDC 66993-936-61 Storage and Handling Store at controlled room temperature: 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
Indications & Usage
1 INDICATIONS AND USAGE Metronidazole Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Cleanse treated areas before the application of Metronidazole Gel, 1%. Apply and rub in a thin film of Metronidazole Gel, 1% once daily to affected area(s). Cosmetics may be applied after the application of Metronidazole Gel, 1%. For topical use only, not for oral, ophthalmic, or intravaginal use. Cleanse treated areas before the application of Metronidazole Gel, 1% ( 2 ) Apply and rub in a thin film of Metronidazole Gel, 1% once daily to affected area(s). ( 2 ) Cosmetics may be applied after the application of Metronidazole Gel, 1%. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )