Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 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; PACKAGE LABEL: MetroCream ® (metronidazole topical cream) TOPICAL CREAM 0.75% NET WT. 45 g NDC 0299-3836-45 Rx only GALDERMA FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20°-25°C), EXCURSIONS PERMITTED BETWEEN 59° AND 86°F (15° - 30°C). Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes. Each gram contains: Active: metronidazole 0.75% (7.5 mg). Inactive: benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. See closure for lot number and expiration date. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, TX 76177 USA Made in Canada All trademarks are the property of their respective owners. P53315-0
- HOW SUPPLIED: 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
- PACKAGE LABEL: MetroCream ® (metronidazole topical cream) TOPICAL CREAM 0.75% NET WT. 45 g NDC 0299-3836-45 Rx only GALDERMA FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20°-25°C), EXCURSIONS PERMITTED BETWEEN 59° AND 86°F (15° - 30°C). Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes. Each gram contains: Active: metronidazole 0.75% (7.5 mg). Inactive: benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and/or sodium hydroxide to adjust pH. See closure for lot number and expiration date. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, TX 76177 USA Made in Canada All trademarks are the property of their respective owners. P53315-0
Overview
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 C 6 H 9 N 3 O 3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:
Indications & Usage
: METROCREAM ® (metronidazole topical cream) 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 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.
Warnings & Precautions
No warnings available yet.
Contraindications
: METROCREAM ® (metronidazole topical cream) 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 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.
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