Drug Catalog - Product Detail
METRONIDAZOLE CREAM 0.75% CRM 45GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 66993-0960-45 | PRASCO LABORATORIES | 45 | 0.75% | CREAM |
PACKAGE FILES
Generic Name
METRONIDAZOLE
Substance Name
METRONIDAZOLE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA020531
Description
DESCRIPTION: Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1 H - imidazole-1-ethanol. The molecular formula is C 6 H 9 N 3 O 3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula: metro-crm-chem-struct
How Supplied
HOW SUPPLIED: Metronidazole Topical Cream, 0.75% is supplied in a 45 g aluminum tube - NDC 66993-960-45 . Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° TO 25°C), EXCURSIONS PERMITTED BETWEEN 59° TO 86°F (15° TO 30°C). Marketed by: Prasco Laboratories Mason, OH 45040 USA Made in Canada P53365-0 Issued: March 2017
Indications & Usage
INDICATIONS AND USAGE: Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Dosage and Administration
DOSAGE AND ADMINISTRATION: Apply and rub in a thin layer of Metronidazole Topical Cream twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of Metronidazole Topical Cream.