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

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 13, 2024

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  • Drug Facts

  • Active ingredients(in each gram)

    Bacitracin zinc (bacitracin 400 units)

    Neomycin sulfate (neomycin 3.5 mg)

    Polymyxin B sulfate

    (polymyxin B 5,000 units)

  • Purpose

    first aid

    antibiotic

  • Uses

    first aid to help prevent infection in minor cuts, scrapes, and burns

  • Warnings

    For external use only

  • 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 puntucre wounds
    • animal bites
    • serious burns
  • 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, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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.
  • Other Information

    store at room temperature

  • Inactive ingredients

    Mineral oil,  petrolatum, purified water

  • PRINCIPAL DISPLAY PANEL

    box label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, polymyxin b cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82942-1002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [CFU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [CFU]  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:82942-1002-10.9 g in 1 PACKET; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00410/01/2022
    Labeler - J&A Digital Inc. (040268672)
    Registrant - J&A Digital Inc. (040268672)
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