Metronidazole METRONIDAZOLE TARO PHARMACEUTICALS U.S.A., INC. FDA Approved Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H -imidazole-1-ethanol and has the following structure: Chemical Structure
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Substance Metronidazole
Route
TOPICAL
Applications
ANDA077819

Drug Facts

Composition & Profile

Strengths
0.75 % 5 g 30 g 45 g
Quantities
2 count
Treats Conditions
Indications And Usage Metronidazole Gel Is Indicated For Topical Application In The Treatment Of Inflammatory Papules And Pustules Of Rosacea
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOX
UNII
140QMO216E
Packaging

HOW SUPPLIED Metronidazole Gel USP, 0.75% is supplied in aluminum tubes containing: 5 g NDC 51672-4116-5 (physician sample, tube only) 30 g NDC 51672-4116-2 45 g NDC 51672-4116-6 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 51672-4116-2 Metronidazole Gel USP, 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 30 g Rx only TARO PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Package Descriptions
  • HOW SUPPLIED Metronidazole Gel USP, 0.75% is supplied in aluminum tubes containing: 5 g NDC 51672-4116-5 (physician sample, tube only) 30 g NDC 51672-4116-2 45 g NDC 51672-4116-6 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 51672-4116-2 Metronidazole Gel USP, 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 30 g Rx only TARO PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Overview

Metronidazole gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1 H -imidazole-1-ethanol and has the following structure: Chemical Structure

Indications & Usage

Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Dosage & Administration

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

Warnings & Precautions
No warnings available yet.
Contraindications

Metronidazole gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

Adverse Reactions

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.

Drug Interactions

Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Storage & Handling

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].


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