TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [KAREWAY PRODUCT, INC.]

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  • TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [KAREWAY PRODUCT, INC.]

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [KAREWAY PRODUCT, INC.]
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NDC 67510-0670-1, 67510-0670-3, 67510-0670-5
Set ID 395e9db3-dea8-4ba6-b88a-8a7851c5ad90
Category HUMAN OTC DRUG LABEL
Packager Kareway Product, Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • Active ingredients (in each gram)

    Bacitracin Zinc 500 units
    Neomycin 3.5mg
    Polymyxin B Sulfate 10,000 units
    Pramoxine HCl 10mg
  • 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 HCI 10 mgExternal analgesic
  • Uses

    First aid to help prevent infection and provide temporary relief of pain or discomfort 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

    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
    • condition persists 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
      • 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: consult a physician
  • Other information

    store at 20°-25°C (68°-77°F)
  • PRINCIPAL DISPLAY PANEL

    Triple Antibiotic Ointment + Pain Relief
    Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

    First Aid Antibiotic Ointment

    Maximum Strengthimage of carton label

    NET WT 1 oz (28.3 g)


  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    External analgesic

  • Inactive ingredients

    white petrolatum

  • 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:67510-0670
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES) Bacitracin Zinc500 [iU]  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 B Sulfate10000 [iU]  in 1 g
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0670-31 in 1 CARTON
    19.4 g in 1 TUBE
    2NDC:67510-0670-11 in 1 CARTON
    228.3 g in 1 TUBE
    3NDC:67510-0670-51 in 1 CARTON
    314 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B09/12/2011
    Labeler - Kareway Product, Inc. (121840057)
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