Label: ROSADAN- metronidazole gel
ROSADAN- metronidazole kit

  • NDC Code(s): 43538-182-45, 43538-183-45
  • Packager: Medimetriks Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 13, 2019

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  • SPL UNCLASSIFIED SECTION

    FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)

    Rx Only

  • DESCRIPTION

    Rosadan® (metronidazole) Gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer homopolymer NF, 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:

    Chemical Structure
  • CLINICAL PHARMACOLOGY

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

  • INDICATIONS AND USAGE

    Rosadan® (metronidazole) Gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

  • CONTRAINDICATIONS

    Rosadan® (metronidazole) Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

  • PRECAUTIONS

    General

    Metronidazole 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 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 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.

    To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

  • DOSAGE AND ADMINISTRATION

    Apply and rub in a thin film of Rosadan ® (metronidazole) Gel twice daily, morning and evening, to entire affected areas after washing.

    Areas to be treated should be cleansed before application of Rosadan ® (metronidazole) Gel. Patients may use cosmetics after application of Rosadan ® (metronidazole) Gel.

  • HOW SUPPLIED

    Rosadan ® (metronidazole) Gel USP, 0.75% is supplied in a 45 g tube NDC 43538-182-45

    Storage conditions

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

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    MEDIMETRIKS
    PHARMACEUTICALS, INC.

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

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

    8-0637BFMDMLNC2
    Rev. 08/2019
    GW 7313
    IP024-R4

  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    NDC 43538-182-45

    Rx Only

    Rosadan® GEL
    Metronidazole Gel USP, 0.75%

    NET WT 45 g

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

    NDC 43538-183-45

    Rx Only
    Rosadan®
    Metronidazole Gel USP, 0.75%
    GEL KIT

    CONTENTS:

    1-
    Rosadan®
    Metronidazole Gel USP,
    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
  • INGREDIENTS AND APPEARANCE
    ROSADAN 
    metronidazole gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-182
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    metronidazole (UNII: 140QMO216E) (metronidazole - UNII:140QMO216E) metronidazole7.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    edetate disodium (UNII: 7FLD91C86K)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43538-182-451 in 1 CARTON04/15/2012
    145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07817804/15/2012
    ROSADAN 
    metronidazole kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-183
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43538-183-451 in 1 CARTON; Type 0: Not a Combination Product08/01/2011
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 45 g
    Part 21 BOTTLE, PUMP 454 g
    Part 1 of 2
    ROSADAN 
    metronidazole gel
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    metronidazole (UNII: 140QMO216E) (metronidazole - UNII:140QMO216E) metronidazole7.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    edetate disodium (UNII: 7FLD91C86K)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07817804/15/2012
    Part 2 of 2
    REHYLA WASH 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRwater (UNII: 059QF0KO0R)  
    INGRglyceryl monostearate (UNII: 230OU9XXE4)  
    INGRglycerin (UNII: PDC6A3C0OX)  
    INGRcetyl alcohol (UNII: 936JST6JCN)  
    INGRdisodium oleamido mipa-sulfosuccinate (UNII: 0MBZ20845F)  
    INGRcholesterol (UNII: 97C5T2UQ7J)  
    INGRdisodium laureth sulfosuccinate (UNII: D6DH1DTN7E)  
    INGRcaprylyl glycol (UNII: 00YIU5438U)  
    INGRpropylene glycol (UNII: 6DC9Q167V3)  
    INGRphenoxyethanol (UNII: HIE492ZZ3T)  
    INGRsodium cocoyl isethionate (UNII: 518XTE8493)  
    INGRcocamidopropyl betaine (UNII: 5OCF3O11KX)  
    INGRsodium methyl cocoyl taurate (UNII: JVL98CG53G)  
    INGRC13-14 isoparaffin (UNII: E4F12ROE70)  
    INGRsodium chloride (UNII: 451W47IQ8X)  
    INGRniacinamide (UNII: 25X51I8RD4)  
    INGRedetate disodium (UNII: 7FLD91C86K)  
    INGRhexylene glycol (UNII: KEH0A3F75J)  
    INGRlaureth-7 (UNII: Z95S6G8201)  
    INGRchamaemelum nobile flower (UNII: O2T154T6OG)  
    INGRhyaluronate sodium (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    1454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07817808/01/2011
    Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosette Pharmaceuticals, Inc.116918230MANUFACTURE(43538-182, 43538-183)