Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Metronidazole Topical Cream, 0.75% is supplied in a: 45 g aluminum tube NDC 59651-770-46 Storage conditions : Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: March 2025; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Label NDC 59651-770-46 Rx only Metronidazole Topical Cream 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT. 45 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 59651-770-46 Rx only Metronidazole Topical Cream 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT. 45 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
- HOW SUPPLIED: Metronidazole Topical Cream, 0.75% is supplied in a: 45 g aluminum tube NDC 59651-770-46 Storage conditions : Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: March 2025
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Label NDC 59651-770-46 Rx only Metronidazole Topical Cream 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT. 45 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 59651-770-46 Rx only Metronidazole Topical Cream 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO NET WT. 45 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube 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 benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid and sodium hydroxide to adjust pH, purified water and sorbitol solution. 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: str
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. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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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