Label: FIRST AID ONLY 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 June 7, 2023

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  • Drug Facts

  • Active Ingredients (in each gram)

    Bacitracin zinc 400 units

    Neomycin sulfate 5 mg (equivalent to 3.5 mg of neomycin base)

    Polymyxin B sulfate 5000 units

    Purpose

    First Aid Antibiotic

  • Uses

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

  • Warnings

    For external use only

    Do not use

    • In the 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
    • on deep lacerations or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • condition persists or gets worse
    • a rash or allergic reaction occurs
    • the condition persists for more than 7 days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • clean the affected area
    • apply small amount 1 to 3 times daily
    • may be covered with a sterile bandage
  • Other Information

    Store at room temperature

  • Inactive Ingredient

    white petrolatum

  • Questions

    1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Box Label Box Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5618(NDC:61040-226)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5618-0460 in 1 BOX02/24/2023
    10.5 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0924-5618-000.5 g in 1 POUCH; Type 0: Not a Combination Product02/24/2023
    3NDC:0924-5618-0212 in 1 BOX06/12/2023
    30.5 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0924-5618-0325 in 1 BOX06/12/2023
    40.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/24/2023
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5618) , repack(0924-5618)
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