Label: BACITRACIN ZINC, NEOMYCIN SULFATE AND 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 9, 2012

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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

  • Uses:

    First aid to help prevent infection in:
    • Minor cuts
    • scrapes
    • burns
  • Ask a doctor before use:

    • 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:

    • White petrolatum
  • Keep Out Of Reach Of Children

    KEEP OUT OF REACH OF CHILDREN

    • If swallowed get medical help or contact a Poison Control Center right away.
  • 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

    Sion Biotext Medical Ltd

    Triple Antibiotic Ointment

    SBM Triple.jpg

    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:68786-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN ZINC - UNII:89Y4M234ES) BACITRACIN ZINC400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68786-216-0572 in 1 CASE
    128.35 g in 1 TUBE
    2NDC:68786-216-0112 in 1 CASE
    2144 in 1 BOX
    20.9 g in 1 PACKET
    3NDC:68786-216-0312 in 1 CASE
    3144 in 1 BOX
    30.5 g in 1 PACKET
    4NDC:68786-216-041728 in 1 CASE
    40.5 g in 1 PACKET
    5NDC:68786-216-021728 in 1 CASE
    50.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/09/2012
    Labeler - Sion Biotext Medical Ltd (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture
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