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

  • NDC Code(s): 69396-002-05, 69396-002-09, 69396-002-20, 69396-002-22, view more
    69396-002-23, 69396-002-25, 69396-002-44
  • Packager: TRIFECTA PHARMACEUTICALS USA LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 29, 2024

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  • Active ingredients (each gram contains)

    Bacitracin zinc 400 units
    Neomycin sulfate 3.5 mg 
    Polymyxin B sulfate 5,000 units

  • Purpose

    First aid antibiotic

  • 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.

  • INDICATIONS & USAGE

    Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

  • WARNINGS

    Warnings    For external use only.

    Do not use ● in the eyes                             ● over large areas of the body

                       ● if you are allergic to any of the ingredients.

    Ask a doctor before use if you have

    ● deep or puncture wounds                     ● animal bites                        ● serious burns.

    Stop use and ask a doctor if ● condition persists or gets worse

    ● you need to use longer than 1 week

    ● a rash or other allergic reaction develops 

  • Directions

     ● clean the affected area and dry thoroughly.

     ● apply a small amount of this 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 INGREDIENT

    Inactive ingredient light Mineral Oil, White Petrolatum

  • Other information

    ● To open: unscrew cap, pull tab to remove foil seal
    ● store at 20° to 25°C ( 68° to 77°F)

    ● see carton or tube for lot number and expiration date.

  • QUESTIONS

    Questions?  Call 1-888-296-9067

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Trifecta Pharmaceuticals USA™
    101 NE Third Avenue, Suite 1500
    Ft. Lauderdale, FL 33301, USA
    1-888-296-9067

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-002-201 in 1 BOX03/13/2017
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-002-051 in 1 BOX08/23/2016
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69396-002-09144 in 1 BOX03/09/2022
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:69396-002-2525 in 1 BOX03/14/2023
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:69396-002-221 in 1 BOX02/01/2022
    557 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:69396-002-232 in 1 BOX02/29/2024
    628.4 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:69396-002-444 in 1 BOX02/29/2024
    728.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00403/10/2015
    Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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