MetroCream

METROCREAM® (metronidazole topical cream) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Apply and rub in a thin layer of METROCREAM® (metronidazole topical cream) 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 METROCREAM® (metronidazole topical cream) Topical Cream.

In controlled clinical trials, the total incidence of adverse reactions associated with the use of METROCREAM® 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.

METROCREAM® 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, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

METROCREAM® (metronidazole topical cream) Topical Cream, 0.75% is supplied in a 45 g aluminum tube - NDC 0299-3836-45.

Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE, 68° to 77°F (20° to 25°C), EXCURSIONS PERMITTED BETWEEN 59° AND 86°F (15° - 30°C).

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Made in Canada
All trademarks are the property of their respective owners.
P53314-0
Revised: January 2017