Metronidazole

Product Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form:

NDC: 0713-0633

Application: ANDA077549

Effective: 20231129

INDICATIONS AND USAGE Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

DOSAGE AND 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.

CONTRAINDICATIONS Metronidazole Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

Not available.

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.