Label: WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, poymyxin b sulfate, and pramoxine hydrochrloride ointment

  • 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 18, 2022

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  • ACTIVE INGREDIENT

    Active ingredients                                                                                                       Purpose

    Bacitracin zinc 500 units.............................................................................First aid antibiotic

    Neomycin sulfate 3.5 mg............................................................................First aid antibiotic

    Polymyxin B sulfate 10,000 units.................................................................First aid antibiotic

    Pramoxine hydrochloride 10 mg..................................................................External analgesic

  • PURPOSE

    Uses

    first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

    • cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • the condition persists or gets worse
    • symptoms persist for more than 1 week, or clear up and occur again within a few days
    • rash or other allergic reaction develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    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: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store between 20° to 25°C (68° to 77°F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • Inactive Ingredients ;

     petrolatum

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

  • Principle Display Panel -TUBE 

    WinCo Foods                           NDC 67091-272-28

    Triple Antibiotic Plus Ointment 

    • Bacitracin Zinc   
    • Neomycin Sulfate 
    • Polymyxin B Sulfate 
    • Pramoxine HCL 

    NET WT 1 OZ (28g)

    Triple Plus Pain Tube-01.jpg

  • Principle Display Panel -CARTON 

    WinCo Foods                        NDC 67091-272-28

    Triple Antibiotic Plus Ointment 

    • Bacitracin Zinc
    • Neomycin Sulfate 
    • Polymyxin B Sulfate 
    • Pramoxine HCL 

    NET WT 1 OZ (28g)

    Triple Plus Pain Carton-01.jpg

  • INGREDIENTS AND APPEARANCE
    WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, poymyxin b sulfate, and pramoxine hydrochrloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-272
    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:67091-272-281 in 1 CARTON02/10/2015
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/10/2015
    Labeler - WinCo Foods, LLC (056098817)
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