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NDC 66993-0962-45 Metronidazole Topical Gel 7.5 mg/g Details

Metronidazole Topical Gel 7.5 mg/g

Metronidazole Topical Gel is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Prasco Laboratories. The primary component is METRONIDAZOLE.

MedlinePlus Drug Summary

Metronidazole is used to treat rosacea (a skin disease that causes redness, flushing, and pimples on the face). Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria.

Related Packages: 66993-0962-45
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Metronidazole Topical

Product Information

NDC	66993-0962
Product ID	66993-962_3c2c4df2-5e31-4392-b39c-7aa8fedf84f5
Associated GPIs	90060040004010
GCN Sequence Number	041798
GCN Sequence Number Description	metronidazole GEL (GRAM) 0.75 % TOPICAL
HIC3	L5G
HIC3 Description	ROSACEA AGENTS, TOPICAL
GCN	43202
HICL Sequence Number	004157
HICL Sequence Number Description	METRONIDAZOLE
Brand/Generic	Generic
Proprietary Name	Metronidazole Topical Gel
Proprietary Name Suffix	n/a
Non-Proprietary Name	metronidazole
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	7.5
Active Ingredient Units	mg/g
Substance Name	METRONIDAZOLE
Labeler Name	Prasco Laboratories
Pharmaceutical Class	Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
DEA Schedule	n/a
Marketing Category	NDA AUTHORIZED GENERIC
Application Number	NDA019737
Listing Certified Through	2024-12-31

Package

Package Images

NDC 66993-0962-45 (66993096245)

Pricing Information
NDC Package Code	66993-962-45
Billing NDC	66993096245
Package	1 TUBE in 1 CARTON (66993-962-45) / 45 g in 1 TUBE
Marketing Start Date	2014-03-01
NDC Exclude Flag	N
Price Per Unit	0.44669
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	METRONIDAZOLE TOPICAL 0.75% GL
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	1, 5, 6
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 49b16ff1-299d-4dd0-82a7-fdb9c6e7c7a0 Details

DESCRIPTION:

Metronidazole Topical 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-1H-imidazole-1-ethanol and has the following structure:

CLINICAL PHARMACOLOGY:

Bioavailability studies on the topical administration of 1 gram of Metronidazole Topical Gel (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 Topical Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

INDICATIONS AND USAGE:

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

CONTRAINDICATIONS:

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

PRECAUTIONS:

General:

Metronidazole Topical Gel has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.

Information for patients:

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

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.

Carcinogenesis, mutagenesis, impairment of fertility:

Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.

Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn’s disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.

Pregnancy:

Teratogenic effects: Pregnancy category B: There has been no experience to date with the use of Metronidazole Topical Gel in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.

Nursing mothers:

After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though Metronidazole Topical Gel blood levels are significantly lower than those achieved after oral metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use:

Safety and effectiveness in pediatric patients have not been established.

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.

DOSAGE AND ADMINISTRATION:

Apply and rub in a thin film of Metronidazole Topical Gel twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of Metronidazole Topical Gel. Patients may use cosmetics after application of Metronidazole Topical Gel.

HOW SUPPLIED:

Metronidazole Topical Gel is supplied in a 45 g aluminum tube – NDC 66993-962-45.

Storage conditions:

STORE AT CONTROLLED ROOM TEMPERATURE: 68° to 77°F (20° to 25°C).

Marketed by:

Prasco Laboratories

Mason, OH 45040 USA

P52259-1

Revised: September 2014

PACKAGE LABEL - 45g Carton

Prasco

NDC 66993-962-45

NET WT. 45 g

Metronidazole Topical Gel 0.75%

TOPICAL GEL

Rx Only

FOR TOPICAL USE ONLY. NOT FOR OPTHALMIC USE.

STORE AT CONTROLLED ROOM TEMPERATURE, 68° to 77°F (20° - 25°C).

KEEP OUT OF REACH OF CHILDREN.

Ususal dosage: Apply a thin film to the entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes.

Each gram contains: 7.5 mg of metronidazole as the active ingredient with 0.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives in a gel consisting of carbomer 940, edetate disodium, propylene glycol, purified water, and sodium hydroxide.

Marketed By:

Prasco Laboratories

Mason, OH 45040 USA

Made in Canada.

P52258-2

INGREDIENTS AND APPEARANCE

METRONIDAZOLE TOPICAL GEL

metronidazole gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:66993-962
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METRONIDAZOLE (UNII: 140QMO216E) (Metronidazole - UNII:140QMO216E)	METRONIDAZOLE	7.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66993-962-45	1 in 1 CARTON	03/01/2014
1		45 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA authorized generic	NDA019737	03/01/2014

Labeler - Prasco Laboratories (065969375)

Registrant - Galderma Laboratories, L.P. (047350186)

Name	Address	ID/FEI	Business Operations
Establishment
G Production Inc.		251676961	manufacture(66993-962)

Revised: 2/2019

Document Id: 3c2c4df2-5e31-4392-b39c-7aa8fedf84f5

Set id: 49b16ff1-299d-4dd0-82a7-fdb9c6e7c7a0

Version: 4

Effective Time: 20190212