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NDC 66993-0960-45 METRONIDAZOLE 7.5 mg/g Details

METRONIDAZOLE 7.5 mg/g

METRONIDAZOLE is a TOPICAL CREAM 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: 66993-0960-45
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Metronidazole Topical

Product Information

NDC	66993-0960
Product ID	66993-960_f6a66334-2758-4eda-a6d8-881ecb1d5e37
Associated GPIs	90060040003710
GCN Sequence Number	041799
GCN Sequence Number Description	metronidazole CREAM (G) 0.75 % TOPICAL
HIC3	L5G
HIC3 Description	ROSACEA AGENTS, TOPICAL
GCN	43203
HICL Sequence Number	004157
HICL Sequence Number Description	METRONIDAZOLE
Brand/Generic	Generic
Proprietary Name	METRONIDAZOLE
Proprietary Name Suffix	n/a
Non-Proprietary Name	METRONIDAZOLE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CREAM
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	NDA020531
Listing Certified Through	2024-12-31

Package

Package Images

NDC 66993-0960-45 (66993096045)

Pricing Information
NDC Package Code	66993-960-45
Billing NDC	66993096045
Package	1 TUBE in 1 CARTON (66993-960-45) / 45 g in 1 TUBE
Marketing Start Date	2009-06-18
NDC Exclude Flag	N
Price Per Unit	0.35622
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	METRONIDAZOLE 0.75% CREAM
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 a6ce81f5-a5c6-44d7-b5f0-61d0530345bd Details

DESCRIPTION:

Metronidazole 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 antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H- imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

CLINICAL PHARMACOLOGY:

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

INDICATIONS AND USAGE:

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

CONTRAINDICATIONS:

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

PRECAUTIONS:

General:

Topical metronidazole 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 warfarin and coumarin anticoagulants, 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 are no adequate and well-controlled studies with the use of Metronidazole Topical Cream in pregnant women. 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 blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of 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:

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

DOSAGE AND ADMINISTRATION:

Apply and rub in a thin layer of Metronidazole 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 Metronidazole Topical Cream.

HOW SUPPLIED:

Metronidazole Topical Cream, 0.75% is supplied in a 45 g aluminum tube - NDC 66993-960-45.

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

Marketed by:

Prasco Laboratories

Mason, OH 45040 USA

Made in Canada

P53365-0

Issued: March 2017

Package Label

PRASCO NDC 66993-960-45

NET WT. 45 g

Metronidazole Topical Cream 0.75%

Rx Only

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

STORE AT CONTROLLED ROOM TEMPERATURE, 68° TO 77°F (20° TO 25°C), EXCURSIONS PERMITTED BETWEEN 59° TO 86°F (15° TO 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:

Prasco Laboratories

Mason, OH 45040 USA

Made in Canada

Rev. 1/2017

P53366-0

INGREDIENTS AND APPEARANCE

METRONIDAZOLE

metronidazole cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:66993-960
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
LACTIC ACID (UNII: 33X04XA5AT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66993-960-45	1 in 1 CARTON	06/18/2009
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	NDA020531	06/18/2009

Labeler - Prasco Laboratories (065969375)

Name	Address	ID/FEI	Business Operations
Establishment
DPT Laboratories Ltd.		832224526	manufacture(66993-960)

Name	Address	ID/FEI	Business Operations
Establishment
G Production Inc.		251676961	manufacture(66993-960)

Revised: 2/2019

Document Id: f6a66334-2758-4eda-a6d8-881ecb1d5e37

Set id: a6ce81f5-a5c6-44d7-b5f0-61d0530345bd

Version: 4

Effective Time: 20190205