MetroCream 7.5 mg/g

metronidazole · CREAM · Galderma Laboratories, L.P.

No Recall HistoryCurrently in Shortage

Plain English

MetroCream is a cream containing metronidazole at 7.5 mg/g, taken topical. Manufactured by Galderma Laboratories, L.P..

Key Facts

Brand Name: MetroCream
Generic Name: metronidazole
NDC Code (Product): 0299-3836
Manufacturer: Galderma Laboratories, L.P.
Strength: 7.5 mg/g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: NDA020531
Drug Class: Nitroimidazole Antimicrobial [EPC]
Marketing Start: 09/20/1995

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective4,480 reports

nausea3,392 reports

off label use3,230 reports

diarrhoea2,666 reports

vomiting2,262 reports

pyrexia2,247 reports

headache2,191 reports

pain2,095 reports

abdominal pain2,047 reports

fatigue1,913 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

DOSAGE AND 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.

Contraindications

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

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.

Frequently Asked Questions

What is MetroCream used for?

MetroCream contains metronidazole. It is a cream taken topical. Consult your doctor for specific uses.

Is MetroCream a controlled substance?

MetroCream is not classified as a controlled substance by the DEA.

What is the generic name for MetroCream?

The generic name for MetroCream is metronidazole. There are 12 other brand versions of metronidazole.

What is the NDC code for MetroCream 7.5 mg/g?

The NDC (National Drug Code) for MetroCream 7.5 mg/g is 0299-3836, listed by Galderma Laboratories, L.P..

Product NDC

0299-3836

Package NDC

0299-3836-45

Other Metronidazole Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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