Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Metronidazole Topical Cream, 0.75% is supplied in a 45 g tube NDC 0713-0633-37.; PRINCIPAL DISPLAY PANEL NDC 0713-0633-37 Metronidazole Topical Cream 0.75% 45 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. 45 mg Carton
- HOW SUPPLIED Metronidazole Topical Cream, 0.75% is supplied in a 45 g tube NDC 0713-0633-37.
- PRINCIPAL DISPLAY PANEL NDC 0713-0633-37 Metronidazole Topical Cream 0.75% 45 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. 45 mg Carton
Overview
Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. 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: Chemical Structure Diagram
Indications & Usage
Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Dosage & 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.
Warnings & Precautions
No warnings available yet.
Contraindications
Metronidazole Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.
Adverse Reactions
In controlled clinical trials, the total incidence of adverse reactions associated with the use of Metronidazole Topical Cream was approximately10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: 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.
Storage & Handling
Storage conditions: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from Freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0633CPLNC2 VC7649 Rev. 08/2022
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