Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • NDC Code(s): 69396-135-10, 69396-135-25
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 24, 2023

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  • Active Ingredient

    Bacitracin Zinc 400 Units

  • Purpose

    First Aid Antibiotic

  • Active ingredient

    Neomycin Sulfate 3.5 mg

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Polymyxin B Sulfate 5000 Units

  • Purpose

    First Aid Antibiotic

  • Uses

    First Aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For External Use Only.

  • Ask Doctor before use if you have

    deep or puncture wounds

    animal bites

    serious burns

  • Do Not Use

    • in eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
  • Stop Use and Ask Doctor if

    • If conidition persists or gets worse
    • You need to use longer than 1 week
    • A rash or allergic reaction develops
  • Directions

    • Clean the affected area and dry thoroughly
    • Apply a small amount of the 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
  • Inactive Ingredients

    light mineral oil and white petrolatum

  • Questions

    Call 1-888-296-9067

  • Storage Information

    Store at 20° to 25°C (68° to 77°F).

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Other Information

    Distributed By:

    Trifecta Pharmaceuticals USA®

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

    Reorder: R519-545

  • Package Label

    R519545 Globe Triple Antibiotic Ointment 0.9g 25ct 082823 CDER

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-135-1010 in 1 CARTON10/23/2023
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69396-135-2525 in 1 CARTON10/23/2023
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00410/23/2023
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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