Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 fl. oz. (59 mL) plastic bottle – NDC 68308- 712 -59 Storage: Store at controlled room temperature 68° - 77°F (20° - 25°C). Protect from freezing. Marketed By: Mayne Pharma Raleigh, NC 27609 1-844-825-8500 Product of Canada P58196-0 Revised Sept 2024; PACKAGE LABEL NDC 68308- 712 -59 Metronidazole Lotion 0.75% Topical Lotion Rx Only 2 FL OZ (59 mL) maynepharma STORE AT CONTROLLED ROOM TEMPERATURE 68° TO 77° (20°-25°C). PROTECT FROM FREEZING. Distributed by: Mayne Pharma Raleigh, NC 27609 Product of Canada P58197-0 FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. 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% w/w (7.5 mg). Inactive: benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. See lot number and expiration date on bottom of carton.
- HOW SUPPLIED Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 fl. oz. (59 mL) plastic bottle – NDC 68308- 712 -59 Storage: Store at controlled room temperature 68° - 77°F (20° - 25°C). Protect from freezing. Marketed By: Mayne Pharma Raleigh, NC 27609 1-844-825-8500 Product of Canada P58196-0 Revised Sept 2024
- PACKAGE LABEL NDC 68308- 712 -59 Metronidazole Lotion 0.75% Topical Lotion Rx Only 2 FL OZ (59 mL) maynepharma STORE AT CONTROLLED ROOM TEMPERATURE 68° TO 77° (20°-25°C). PROTECT FROM FREEZING. Distributed by: Mayne Pharma Raleigh, NC 27609 Product of Canada P58197-0 FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. 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% w/w (7.5 mg). Inactive: benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. See lot number and expiration date on bottom of carton.
Overview
Metronidazole Topical Lotion contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. Metronidazole is an imidazole 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-chem-struct
Indications & Usage
Metronidazole Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Dosage & Administration
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. Patients may use cosmetics after waiting for the MetronidazoleTopical Lotion to dry (not less than 5 minutes).
Warnings & Precautions
No warnings available yet.
Contraindications
Metronidazole Topical Lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.
Adverse Reactions
In a controlled clinical trial, safety data from 141 patients who used Metronidazole Topical Lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, Metronidazole Topical Lotion 2 (3%), lotion vehicle 0; contact dermatitis, Metronidazole Topical Lotion 2 (3%), lotion vehicle 1 (1%); pruritus, Metronidazole Topical Lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), Metronidazole Topical Lotion 1 (1%), lotion vehicle 2 (3%); erythema, Metronidazole Topical Lotion 4 (6%), lotion vehicle 0; dry skin, MetronidazoleTopical Lotion 0, lotion vehicle 1 (1%); and worsening of rosacea, Metronidazole Topical Lotion 1 (1%), lotion vehicle 7 (10%). The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, 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.
Storage & Handling
Storage: Store at controlled room temperature 68° - 77°F (20° - 25°C). Protect from freezing. Marketed By: Mayne Pharma Raleigh, NC 27609 1-844-825-8500 Product of Canada P58196-0 Revised Sept 2024
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