TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [VALU MERCHANDISERS, CO.]

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TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [VALU MERCHANDISERS, CO.]
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NDC 63941-831-01
Set ID 49376b4d-d2fc-6472-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Valu Merchandisers, Co.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • Active ingredients

    Bacitracin Zinc 400 units

    Neomycin Sulfate 3.5mg

    Polymyxin B Sulfate 5,000 units

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • Warnings

    For external use only

    Ask a doctor before use if you have

    • serious burns
    • deep or puncture wounds
    • animal bites

    When using this product

    • do not use in the eyes
    • do not apply over large areas of the body

    Stop use and ask a doctor if

    • you need to use more 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.
    • 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.

    Do not use

    if you are allergic to any of the ingredients

  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Directions

    • adults and children 2 years of age or 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:  ask a doctor
  • Other information

    • store at 59° to 77°F

  • Inactive ingredients

    cetyl alcohol, mineral oil, petrolatum, squalane, stearic acid, tocopheryl acetate

  • Package label panel

    Triple Antibiotic Ointment

    carton

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-831
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-831-011 in 1 BOX02/22/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/16/2012
    Labeler - Valu Merchandisers, Co. (868703513)
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