Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Metronidazole Topical Cream 0.75% is supplied in a 45 gram tube, NDC 0168-0323-46 Storage conditions: Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 46273863A R07/2020 #29; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM TUBE NDC 0168-0323-46 Fougera® METRONIDAZOLE TOPICAL CREAM 0.75% Rx only FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN. NET WT 45 grams 45gramTubeLabel; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON NDC 0168-0323-46 Rx only Fougera® METRONIDAZOLE TOPICAL CREAM 0.75% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE NET WT 45 grams 45gcarton
- HOW SUPPLIED Metronidazole Topical Cream 0.75% is supplied in a 45 gram tube, NDC 0168-0323-46 Storage conditions: Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 46273863A R07/2020 #29
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM TUBE NDC 0168-0323-46 Fougera® METRONIDAZOLE TOPICAL CREAM 0.75% Rx only FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN. NET WT 45 grams 45gramTubeLabel
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON NDC 0168-0323-46 Rx only Fougera® METRONIDAZOLE TOPICAL CREAM 0.75% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE NET WT 45 grams 45gcarton
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 anti-bacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-Methyl-5-nitroimidazole-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: structure
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.
Storage & Handling
Storage conditions: Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 46273863A R07/2020 #29
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.