Label: BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE ointment

  • NDC Code(s): 67777-217-01, 67777-217-02, 67777-217-05, 67777-217-07
  • Packager: Dynarex Corporation
  • 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 September 18, 2020

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  • ACTIVE INGREDIENT

    Active ingredient (in ea. gram)                                                Purpose           
    Bacitracin Zinc 400 Units                                                          First Aid Antibiotic

    Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)              First Aid Antibiotic

    Polymyxin B Sulfate 5000 Units                                                 First Aid Antibiotic

  • Ask a doctor before use:

    First aid to help prevent infection in:

    • Minor cuts
    • scrapes
    • burns
  • Purpose

    First aid to help prevent infection in:

    • Minor cuts
    • scrapes
    • burns
  • Other information

    • store at controlled room temperature 15°-30° C (59°-86° F)
    • avoid excessive heat and humidity
  • Inactive ingredients:

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • Keep Out Of Reach Of Children

    KEEP OUT OF REACH OF CHILDREN

  • Warnings

    For external use only

  • Dosage and Administration

    • clean the affected areas
    • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • Do Not Use:

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

    • Stop use and ask a doctor if condition persists or gets worse, or if a rash or other allergic reaction occurs
  • Principal Display panel

    1182 BX MASTER1180 BX MASTERDynarex Triple Antibiotic



    triple-antibiotic-ointment-1184-01.jpg

    Triple Antibiotic

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
    bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-217
    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) NEOMYCIN5 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:67777-217-0128.35 g in 1 TUBE; Type 0: Not a Combination Product04/18/2016
    2NDC:67777-217-0214.17 g in 1 TUBE; Type 0: Not a Combination Product04/18/2016
    3NDC:67777-217-050.5 g in 1 PACKET; Type 0: Not a Combination Product04/18/2016
    4NDC:67777-217-070.9 g in 1 PACKET; Type 0: Not a Combination Product04/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2009
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)