RVP

Drug Catalog - Product Detail

METRONIDAZOLE EXT GEL 0.75% 45GM X 1

NDC Mfr Size Str Form
00781-7078-19 SANDOZ 45GM 0.75% NA
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Metronidazole topical gel USP, 0.75%, contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbopol 980, NF; edetate disodium, USP; methylparaben, NF; propylene glycol, USP; propylparaben, NF; purified water, USP; and sodium hydroxide, NF. Metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H -imidazole-1-ethanol and has the following structure: 3e9970ae-figure-01
How Supplied
HOW SUPPLIED Metronidazole topical gel USP, 0.75%, is supplied as the following: NDC 0781-7078-24: 1 oz. (28.4 g) aluminum tube NDC 0781-7078-19: 45 g aluminum tube Storage conditions: Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 04584 Rev. 3 04/10 Manufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 08540
Indications & Usage
INDICATIONS & USAGE Metronidazole topical gel USP, 0.75%, 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 film of metronidazole topical gel USP, 0.75%, twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole topical gel USP, 0.75%. Patients may use cosmetics after application of metronidazole topical gel USP, 0.75%.