Label: TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

  • NDC Code(s): 53943-988-01
  • Packager: Discount Drug Mart, Inc.
  • 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 February 17, 2023

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  • Active ingredients (in each gram)

    Bacitracin Zinc 500 units

    Neomycin 3.5mg

    Polymyxin B Sulfate 10,000 units

    Pramoxine HCl 10mg

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    External analgesic

  • Uses

    First aid to help prevent infection and provide temporary relief of pain or discomfort in minor

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are sensitive or allergic to any ingredient in this product

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • symptoms persists for more than 1 week, or clear up and occur again within a few days
    • 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

    • adults and children 2 years of age and older:
      • 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
    • children under 2 years of age: consult a physician
  • Other information

    store at 20°-25°C (68°-77°F)

  • Inactive ingredient

    white petrolatum

  • PRINCIPAL DISPLAY PANEL

    Triple Antibiotic Ointment Plus Pain Relief

    triple.plus.carton

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-988
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [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 B10000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-988-011 in 1 CARTON10/30/2015
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B10/30/2015
    Labeler - Discount Drug Mart, Inc. (047741335)
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