Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Metronidazole Gel USP, 0.75% is supplied in a 45 g tube NDC 0713-0637-37 Storage conditions: Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0637BFCPLNC3 Rev. 07/2022 VC7647; PRINCIPAL DISPLAY PANEL NDC 0713-0637-37 Metronidazole Gel USP 0.75% 45 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0637-37 Metronidazole Gel USP 0.75% 45 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. carton tube
- HOW SUPPLIED: Metronidazole Gel USP, 0.75% is supplied in a 45 g tube NDC 0713-0637-37 Storage conditions: Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0637BFCPLNC3 Rev. 07/2022 VC7647
- PRINCIPAL DISPLAY PANEL NDC 0713-0637-37 Metronidazole Gel USP 0.75% 45 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0637-37 Metronidazole Gel USP 0.75% 45 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. carton tube
Overview
Metronidazole Gel USP, 0.75% contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer homopolymer NF, edetate disodium,methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H -imidazole-1-ethanol and has the following structure: Structural Formula
Indications & Usage
: Metronidazole Gel USP 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 twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of Metronidazole Gel. Patients may use cosmetics after application of Metronidazole Gel.
Warnings & Precautions
No warnings available yet.
Contraindications
: Metronidazole Gel is contraindicated in individuals with a history of hypersensitivity to 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. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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