Label: ROSADAN- metronidazole cream

  • NDC Code(s): 43538-180-45, 43538-181-45
  • Packager: Medimetriks Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 08/11

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  • SPL UNCLASSIFIED SECTION

    FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)

    Rx only

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  • DESCRIPTION

    Rosadan™ (metronidazole) Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of anti-bacterial 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:

    Chemical Structure
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  • CLINICAL PHARMACOLOGY

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

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  • INDICATIONS AND USAGE

    Rosadan™ (metronidazole) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

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  • CONTRAINDICATIONS

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

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  • 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 Rosadan™ (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.

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  • ADVERSE REACTIONS

    In controlled clinical trials, the total incidence of adverse reactions associated with the use of topical metronidazole 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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  • DOSAGE AND ADMINISTRATION

    Apply and rub in a thin layer of Rosadan™ (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 Rosadan™ (metronidazole) Topical Cream.

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  • HOW SUPPLIED

    Rosadan™ (metronidazole) Topical Cream, 0.75% is supplied in a 45 g tube - NDC 43538-180-45.

    Storage conditions

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

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  • SPL UNCLASSIFIED SECTION

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    Manufactured for:
    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    363 Route 46 West
    Fairfield, NJ 07004-2402 USA
    www.medimetriks.com

    Manufactured by:
    G&W Laboratories, Inc.
    South Plainfield, NJ 07080

    IP019

    8-0633MDM1
    Issued 02/11

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  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    NDC 43538-180-45

    RX Only
    Rosadan
    Metronidazole Topical Cream, 0.75%

    NET WT 45 g

    PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
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  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC 43538-181-45

    RX Only
    Rosadan
    Metronidazole Topical Cream, 0.75%
    CREAM KIT

    CONTENTS:
    1-Rosadan™ Metronidazole Topical Cream, 0.75% Tube (Net wt. 45 g)
    1-Rehyla™ Wash Moisturizing Daily Wash Bottle (16 fl. oz.)

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    PRINCIPAL DISPLAY PANEL - Kit Carton
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  • INGREDIENTS AND APPEARANCE
    ROSADAN 
    metronidazole cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-180
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    metronidazole (metronidazole) metronidazole 7.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    sorbitol  
    glycerin  
    isopropyl palmitate  
    benzyl alcohol  
    lactic acid  
    sodium hydroxide  
    water  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43538-180-45 45 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077549 08/30/2011
    ROSADAN 
    metronidazole cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-181
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    metronidazole (metronidazole) metronidazole 7.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    sorbitol  
    glycerin  
    isopropyl palmitate  
    benzyl alcohol  
    lactic acid  
    sodium hydroxide  
    water  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43538-181-45 1 in 1 KIT
    1 45 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077549 08/30/2011
    Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
    Establishment
    Name Address ID/FEI Business Operations
    G&W Laboratories 001271188 MANUFACTURE
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