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

  • NDC Code(s): 69396-015-05, 69396-015-20
  • Packager: Trifecta Pharmaceuticals Usa Llc
  • 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 January 17, 2023

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  • DRUG FACTS

  • Active ingredient (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, 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 crimp 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
    www.trifecta-pharma.com

  • Packaging

    Triple Antibiotic

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate , polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-015
    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:69396-015-051 in 1 BOX03/18/2016
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-015-201 in 1 BOX03/18/2016
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/18/2016
    Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)
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