Label: AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • NDC Code(s): 71927-016-01, 71927-016-03
  • Packager: Orazen Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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  • Active ingredients

    (in each gram)

    Bacitracin zinc 400 units

    Neoycin sulfate equivalent to 3.5 mg of neomycin base

    Polymyxin B sulfate 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
  • Warning

    For external use only.

  • DO NOT USE

    Do not use

    • in eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor

  • Ask a doctor before use if you have

    deep or puncture wounds, animal bites, or serious burns

  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
  • Keep out of reach of children.

    If swallowed contact a Poison Control Center right away.

  • Directions

    • clean affected area
    • apply small amount not more than 3 times daily
    • may be covered with a sterile bandage
  • Inactive Ingredient

    Mineral Oil, Petrolatum, Water

  • PRINCIPAL DISPLAY PANEL

    image of pouch label

    image of box label

  • INGREDIENTS AND APPEARANCE
    AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.0035 g  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-016-03144 in 1 BOX10/17/2022
    1NDC:71927-016-010.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00410/17/2022
    Labeler - Orazen Inc (080916640)
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