Label: TRIPLEANTIBIOTICOINTMENTANDPAINRELIEF- bacitracin,neomycin,polymxin, pramoxine ointment

  • NDC Code(s): 69396-030-01
  • Packager: Trifecta Pharmaceuticals USA
  • 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

    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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