TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]
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NDC 69396-015-05, 69396-015-20
Set ID d04b397c-1608-4fd9-be28-ef7285d6a996
Category HUMAN OTC DRUG LABEL
Packager Trifecta Pharmaceuticals Usa Llc
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • 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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