Label: MUPIROCIN ointment

  • NDC Code(s): 51672-1354-0, 51672-1354-1, 51672-1354-2, 51672-1354-5
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated June 25, 2020

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  • SPL UNCLASSIFIED SECTION

    For dermatologic use on dogs

  • CAUTION

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • DESCRIPTION

    Each gram of mupirocin ointment contains 20 mg of mupirocin in a bland, water-washable ointment base consisting of polyethylene glycol 400 and polyethylene glycol 3350 (polyethylene glycol ointment). Mupirocin is a naturally-occurring, broad-spectrum antibiotic. The chemical name is 9-4-[5S-(2S,3S-epoxy-5S-hydroxy-4S-methylhexyl)-3R,4R-dihydroxytetrahydropyran-2S-yl]-3-methylbut-2(E)-enoyloxy-nonanoic acid. The chemical structure is:

    Chemical Structure
  • CLINICAL PHARMACOLOGY

    Mupirocin is a chemical entity produced by fermentation of the organism Pseudomonas fluorescens. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this mode of action, mupirocin shows no cross resistance with chloramphenicol, erythromycin, gentamicin, lincomycin, neomycin, novobiocin, penicillin, streptomycin, and tetracycline. Mupirocin is an antimicrobial agent that inhibits the growth of gram-positive and gram-negative bacteria.

    Bacteria susceptible to the action of mupirocin in vitro include the aerobic isolates of Staphylococcus aureus (including methicillin-resistant strains and β-lactamase-producing strains), Staphylococcus intermedius, Staphylococcus epidermidis, other coagulase positive or negative Staphylococci, α-hemolytic Streptococci, β group A Streptococci (including S. pyogenes), other β Streptococci (including S. agalactiae), group D Streptococci (including S. faecalis and S. faecium), group Viridans Streptococci, Streptococcus pneumoniae, Corynebacterium hofmanii, Bacillus subtilis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Enterobacter cloacae, Enterobacter aerogenes, Citrobacter freundii, Hemophilus influenzae (including β-lactamase-producing strains), Neisseria gonorrheae (including β-lactamase-producing strains), Neisseria meningitidis, Branhamella catarrhalis and Pasteurella multocida, and the anaerobic isolates of Peptostreptococcus anaerobius, Clostridium difficile, and Clostridium sporogenes.

    Clinical significance of the in vitro data is unknown except for susceptible strains of Staphylcoccus aureus and Staphylococcus intermedius.

  • INDICATIONS FOR USE

    Mupirocin ointment is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.

  • CONTRAINDICATIONS

    This drug is contraindicated in animals with a history of sensitivity reactions to any of its components.

  • WARNINGS

    Because of the potential hazard of nephrotoxicity due to the polyethylene glycol content of the base, care should be exercised when using this product in treating extensive deep lesions where absorption of large quantities of polyethylene glycol is possible.

    Safety of use in pregnant or breeding animals has not been determined.

    Mupirocin ointment is not for ophthalmic use.

  • ADVERSE REACTIONS

    No adverse reactions have been reported with this product. If a skin reaction such as irritation should occur, treatment should be discontinued and appropriate therapy instituted.

  • DOSAGE AND ADMINISTRATION

    Prior to treatment, the lesion should be cleansed. Mupirocin ointment should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the infected area. Maximum duration of treatment should not exceed 30 days.

  • HOW SUPPLIED

    Mupirocin ointment is supplied in 5 g, 15 g, 22 g, and 30 g tubes.

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

    Keep Out of Reach of Children

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under ANADA # 200-457

  • SPL UNCLASSIFIED SECTION

    Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1

    Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

    Revised: January 2020

    PK-6725-2

    TAKE TIME

  • PRINCIPAL DISPLAY PANEL - 22 g Tube Carton

    NDC 51672-1354-0

    Mupirocin
    Ointment USP, 2%

    For dermatologic use on dogs.
    Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
    Approved by FDA under ANADA # 200-457

    Net Weight
    22 g

    Keep Out of Reach of Children.

    TARO

    PRINCIPAL DISPLAY PANEL - 22 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MUPIROCIN 
    mupirocin ointment
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:51672-1354
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Mupirocin (UNII: D0GX863OA5) (Mupirocin - UNII:D0GX863OA5) Mupirocin20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    polyethylene glycol 400 (UNII: B697894SGQ)  
    polyethylene glycol 3350 (UNII: G2M7P15E5P)  
    Product Characteristics
    ColorWHITE (cream-like) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-1354-51 in 1 CARTON
    15 g in 1 TUBE
    2NDC:51672-1354-11 in 1 CARTON
    215 g in 1 TUBE
    3NDC:51672-1354-01 in 1 CARTON
    322 g in 1 TUBE
    4NDC:51672-1354-21 in 1 CARTON
    430 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20045711/29/2010
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd654019884API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Teva Pharmaceutical Works Private Limited Company366709764API MANUFACTURE