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 July 27, 2018

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  • Drug Facts

  • Active ingredients (in each gram)

    Bacitracin zinc, USP 400 units
    Neomycin 3.5 mg
    Polymyxin B sulfate, USP 5,000 units

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help prevent infection in

    • minor cuts 
    • scrapes 
    • burns
  • Warnings

    For external use only

    Allergy alert:

    • do not use if allergic to any of the ingredients

    Do not use

    • in the eyes 
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • 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 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 controlled room temperature 59°-86°F (15°-30°C). Protect from freezing.
    • Before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredient

    white petrolatum

  • Questions?

    1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

  • Principal Display Panel

    pdp

    Triple Antibiotic Oinment

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-640(NDC:0472-0179)
    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:45865-640-011 in 1 CARTON01/01/2018
    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 finalpart333B05/01/1997
    Labeler - Medsource Pharmaceuticals (833685915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medsource Pharmaceuticals833685915repack(45865-640)
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