BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]
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NDC 67777-217-01, 67777-217-02, 67777-217-05, 67777-217-07
Set ID 96d06e4c-c9e7-446f-8b2d-5d030e51d3d3
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • 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)

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