Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Metronidazole gel USP (topical), 0.75%, is supplied as the following: NDC 21922-070-06: 45 g aluminum lube Storage conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285 4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Panda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202Durham, NC 27713 USA Revised: 05/2023; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton Label NDC 21922- 070 -06 Metronidazole Gel USP (Topical), 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. NET WT.45g Rx only carton
- HOW SUPPLIED Metronidazole gel USP (topical), 0.75%, is supplied as the following: NDC 21922-070-06: 45 g aluminum lube Storage conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285 4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Panda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202Durham, NC 27713 USA Revised: 05/2023
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton Label NDC 21922- 070 -06 Metronidazole Gel USP (Topical), 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. NET WT.45g Rx only carton
Overview
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-1H-imidazole-1- ethanol and has the following structure: Structure
Indications & Usage
Metronidazole gel USP (topical), 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Dosage & 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%.
Warnings & Precautions
No warnings available yet.
Contraindications
Metronidazole gel USP (topical), 0.75%, is contraindicated in individuals with a history of hypersensitivity lo metronidazole, parabens, or other ingredients of the formulation.
Adverse Reactions
The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
Drug Interactions
Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
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