BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-008-01, 50382-008-02, 50382-008-03, 50382-008-04
Set ID f562f46c-a764-44f5-b8f4-2d4e97489691
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
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

  • Purpose:

    First aid to help prevent infection in:

    • Minor cuts
    • scrapes
    • burns
  • Indications and Usage:

    • in case of deep or puncture wounds
    • animal bites
    • serious 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

    Galentic Triple Antibiotic Ointment

    Gal Triple.jpg

    Triple Antibiotic Ointment

  • 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:50382-008
    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:50382-008-0128.35 g in 1 TUBE
    2NDC:50382-008-0214.17 g in 1 TUBE
    3NDC:50382-008-0356.7 g in 1 TUBE
    4NDC:50382-008-04113.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/07/2013
    Labeler - Galentic Pharma (India) Private Limited (918531450)

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