TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF (BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]

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TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF (BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]
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NDC 69396-030-01
Set ID 54c1d306-dc3b-2885-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Trifecta Pharmaceuticals USA
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • DRUG FACTS

  • Active Ingredient

    Bacitracin 500 Units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Neomycin 3.5mg

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Polymyxin B 10,000 Units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Pramoxine HCL 10mg

  • Purpose

    External Analgesic

  • Uses

    First Aid to help prevent infection in minor:

    • Cuts
    • Scrapes
    • Burns
  • Warnings

    For external use only. Do not use:

    • In eyes
    • Over large areas of the body
    • If you are allergic to any of the ingredients

  • Ask a Doctor before Use

    Ask Doctor before use if you have:

    • Deep or puncture wouns
    • 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
  • Keep out of Reach of Children

    If Swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Clean the affected area
    • 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
  • 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
  • Inactive Ingredient:

    Light mineral oil, Petrolatum

  • Questions?

    Call 1-888-296-9067

  • Distributed By:

    Trifecta Pharmaceuticals USA ®

    101 NE Third Avenue, Suite 1500

    Fort Lauderdale, FL. 33301 USA

    Product of PRC

    www.trifecta-pharma.com

  • Packaging

    triple antibiotic ointment PDP

  • INGREDIENTS AND APPEARANCE
    TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF 
    bacitracin,neomycin,polymxin, pramoxine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 100 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 100 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 100 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-030-011 in 1 BOX07/20/2017
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/20/2017
    Labeler - Trifecta Pharmaceuticals USA (079424163)
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