Drug Catalog - Product Detail
METRONIDAZOLE TOPICAL GEL GEL 0.01 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-7080-35 | SANDOZ | 60 | 1% | GEL |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
11 DESCRIPTION Metronidazole gel USP, 1% contains metronidazole, USP. It is intended for topical use. 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. Metronidazole gel USP, 1% is a clear, colorless to pale yellow, aqueous gel; each gram contains 10 mg of metronidazole in a base of ceteth-20, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water. efb30dd0-figure-01
How Supplied
16 HOW SUPPLIED 16.1 How Supplied Metronidazole Gel USP, 1% is clear, colorless to pale yellow in color, and supplied as follows: 60 gram tube – NDC 0781-7080-35 55 gram pump – NDC 0781-7080-55 16.2 Storage and Handling Storage Conditions: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS & USAGE Metronidazole gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole gel USP, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )
Dosage and Administration
2 DOSAGE & ADMINISTRATION For topical use only, not for oral, ophthalmic, or intravaginal use. Cleanse treated areas before the application of metronidazole gel USP, 1%. Apply and rub in a thin film of metronidazole gel USP, 1% once daily to affected area(s). Cosmetics may be applied after the application of metronidazole gel USP, 1%. ● Not for oral, ophthalmic, or intravaginal use. ( 2 ) ● Cleanse treated areas before the application of metronidazole gel USP, 1%. ( 2 ) ● Apply and rub in a thin film of metronidazole gel USP, 1% once daily to affected area(s). ( 2 ) ● Cosmetics may be applied after the application of metronidazole gel USP, 1%. ( 2 )