METRONIDAZOLE

Metronidazole gel USP (topical), 0.75%, contains metronidazole, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbopol 980, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1- ethanol and has the following structure:

Structure

Bioavailability studies on the topical administration of 1 gram of metronidazole gel USP (topical), 0.75%, (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients. Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole. The mechanisms by which metronidazole gel USP (topical), 0.75%, acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

Metronidazole gel USP (topical), 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Metronidazole gel USP (topical), 0.75%, is contraindicated in individuals with a history of hypersensitivity lo metronidazole, parabens, or other ingredients of the formulation.

The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

Apply and rub in a thin film of metronidazole gel USP (topical), 0.75%, twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole gel USP (topical), 0.75%. Patients may use cosmetics after application of metronidazole gel USP (topical), 0.75%.

Metronidazole gel USP (topical), 0.75%, is supplied as the following:
NDC 21922-070-06: 45 g aluminum lube

Storage conditions: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285 4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Manufactured by:
Encube Ethicals Pvt. Ltd.
Plot No. C-1, Madkaim Industrial Estate,
Madkaim, Post: Mardol, Panda,
Goa - 403 404, India.

Distributed by:
Encube Ethicals, Inc.
200 Meredith Drive,
Suite 202Durham,
NC 27713 USA

Revised: 05/2023

Carton Label

NDC 21922-070-06

Metronidazole Gel USP (Topical), 0.75%

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.

NET WT.45g

Rx only