Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Metronidazole Topical Cream, 0.75% is supplied in a 45 g aluminum tube - NDC 68308 -711- 45 . Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° TO 25°C), EXCURSIONS PERMITTED BETWEEN 59° AND 86°F (15° TO 30°C). DIstributed by: Mayne Pharma Raleigh, NC 27609 1-844-825-8500 Product of Canada P58249-0 Revised: 10/2024; Package Label NDC 68308- 711 -45 Metronidazole Topical Cream 0.75% Rx Only Net Wt. 45 g maynepharma Product of Canada Distributed by: Mayne Pharma Raleigh, NC 27609 Rev. 10/2024 P58248-0 FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° TO 25°C), EXCURSIONS PERMITTED BETWEEN 59° AND 86°F (15° TO 30°C). Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes. Each gram contains: Active: metronidazole 0.75% (7.5 mg). Inactive: benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. See crimp end for lot number and expiration date.
- HOW SUPPLIED: Metronidazole Topical Cream, 0.75% is supplied in a 45 g aluminum tube - NDC 68308 -711- 45 . Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° TO 25°C), EXCURSIONS PERMITTED BETWEEN 59° AND 86°F (15° TO 30°C). DIstributed by: Mayne Pharma Raleigh, NC 27609 1-844-825-8500 Product of Canada P58249-0 Revised: 10/2024
- Package Label NDC 68308- 711 -45 Metronidazole Topical Cream 0.75% Rx Only Net Wt. 45 g maynepharma Product of Canada Distributed by: Mayne Pharma Raleigh, NC 27609 Rev. 10/2024 P58248-0 FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° TO 25°C), EXCURSIONS PERMITTED BETWEEN 59° AND 86°F (15° TO 30°C). Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes. Each gram contains: Active: metronidazole 0.75% (7.5 mg). Inactive: benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. See crimp end for lot number and expiration date.
Overview
Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. 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: metro-crm-chem-struct
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 approximately 10%. 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.
Drug Interactions
Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
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