Label: TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

  • NDC Code(s): 51672-2027-1, 51672-2027-2
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • ACTIVE INGREDIENT

    Active ingredients (each gram contains)Purpose
    Bacitracin zinc 500 unitsFirst aid antibiotic
    Neomycin sulfate 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
    Pramoxine HCl 10 mgExternal analgesic
  • Uses

    first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    Do not use

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

    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
    • symptoms persist for more than 1 week, or clear up and occur again within a few days
    • a 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

    Adults and children 2 years of age and older:

    • clean the affected area and dry thoroughly
    • 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. Children under 2 years of age: ask a doctor
  • Other information

    • To open: unscrew cap, pull tab to remove foil seal
    • store at 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredient

    white petrolatum

  • Questions?

    Call 1-866-923-4914

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Label

    First Aid Antibiotic
    Pain Relieving Ointment

    Maximum Strength
    Triple Antibiotic
    Ointment + Pain
    Relief

    Bacitracin Zinc ∙ Neomycin Sulfate
    Polymyxin B Sulfate ∙ Pramoxine Hydrochloride

    NET WT 1 oz (28.4 g)

    Principal Display Panel - 28.4 g Tube Label
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2027-11 in 1 CARTON03/31/2012
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51672-2027-21 in 1 CARTON03/31/2012
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00403/31/2012
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(51672-2027)
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