TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SALADO SALES, INC]

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  • TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SALADO SALES, INC]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [SALADO SALES, INC]
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NDC 57243-120-01
Set ID 52e275d3-88c9-47f1-8dcf-68445c7be4a7
Category HUMAN OTC DRUG LABEL
Packager Salado Sales, Inc
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin zinc USP 400 unitsFirst aid antibiotic
    Neomycin sulfate USP 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate USP 5,000 unitsFirst aid antibiotic
  • Uses

    first aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • rash or other allergic reaction develops

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • Other information

    • store at 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by Salado Sales, Inc., Temple, Texas 76503-6115

  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    TRIPLE ANTIBIOTIC
    OINTMENT

    Bacitracin Zinc USP • Neomycin Sulfate USP
    • Polymyxin B Sulfate USP

    FIRST AID ANTIBIOTIC OINTMENT

    NET WEIGHT ½ OZ (14.2 g)

    PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [iU]  in 1 g
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    sucrose (UNII: C151H8M554)  
    cottonseed oil (UNII: H3E878020N)  
    olive oil (UNII: 6UYK2W1W1E)  
    sodium pyruvate (UNII: POD38AIF08)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57243-120-011 in 1 CARTON10/27/2016
    10.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B12/15/2015
    Labeler - Salado Sales, Inc (009830555)
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