Label: TRIPLE ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 11, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (In each gram)

    Bacitracin 400

    Neomycin 3.5 mg

    Polymyxin B 5,000 units

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Allergy alert:

    • do not use if you are allergic to any of the ingredients

    Do not use

    • in or near the eyes
    • on large areas of the body

    Consult a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use longer than 1 week

    Stop use and consult a doctor if

    • condition persists or gets worse
    • symptoms last for more than 7 days or clear up and come back within a few days
    • a rash or other allergic reaction develops

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

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

    • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
  • Inactive ingredient

    Petrolatum

  • Questions? 1-800-222-1087

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66267-931(NDC:11527-162)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66267-931-1514 g in 1 TUBE; Type 0: Not a Combination Product04/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/23/2011
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(66267-931)
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