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Drug Catalog - Product Detail

METRONID GEL 0.75% GPC 45G

NDC Mfr Size Str Form
00115-1474-46 AMNEAL PHARMACEUTICALS 45 0.75% GEL
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Description
DESCRIPTION Metronidazole gel USP (topical), 0.75%, contains metronidazole, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbopol 980, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. 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: 29e089a5-figure-01
How Supplied
HOW SUPPLIED Metronidazole gel USP (topical), 0.75%, is supplied as the following: NDC 0115-1474-46: 45 g aluminum tube Storage and Handling Storage conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 04006127 Rev. 0 04/19
Indications & Usage
INDICATIONS AND USAGE Metronidazole gel USP (topical), 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 gel USP (topical), 0.75%, twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole gel USP (topical), 0.75%. Patients may use cosmetics after application of metronidazole gel USP (topical), 0.75%.