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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each gram)

    Bacitracin Zinc (400 units Bacitracin)

    Neomycin Sulfate (3.5 mg Neomycin)

    Polymyxin B Sulfate (Polymyxin B 5000 units)

  • Purpose

    First Aid Antibiotic

    First Aid Antibiotic

    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 the eyes
    • over large areas of the body
    • on puncture wounds, animal bites, or serious burns
    • longer than 1 week unless directed by a doctor
    • if you are allergic to any of the ingredients

    Stop use and ask a doctor if:

    • a rash or allergic reaction develops
    • condition worsens or persists

    Keep out the reach of children.

  • Directions

    • Clean the affected area.
    • Apply a small amount of product 1 to 3 times daily
    • may be covered with a sterile bandage
  • Inactive Ingredient

    White Petrolatum

  • Questions

    1-800-835-2263

  • PRINCIPAL DISPLAY PANEL

    Box Label Box Label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5604(NDC:61010-5603)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  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 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5604-000.5 g in 1 POUCH; Type 0: Not a Combination Product04/24/2023
    2NDC:0924-5604-016 in 1 BAG04/24/2023
    20.5 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0924-5604-0312 in 1 BOX04/24/2023
    30.5 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0924-5604-0210 in 1 BOX04/24/2023
    40.5 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0924-5604-0420 in 1 BOX04/24/2023
    50.5 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0924-5604-0525 in 1 BOX04/24/2023
    60.5 g in 1 PACKET; Type 0: Not a Combination Product
    7NDC:0924-5604-0660 in 1 BOX04/24/2023
    70.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/24/2023
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5604) , repack(0924-5604)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5604) , repack(0924-5604)
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