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

  • NDC Code(s): 83324-036-01
  • Packager: Chain Drug Marketing Association Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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  • Active ingredients (each gram contains)

    Bacitracin zinc 400 units



    Neomycin sulfate 3.5 mg



    Polymyxin B sulfate 5,000 units

  • Purpose

    First aid antibiotic

  • Active Ingredient

    Pramoxine HCL

  • Purpose

    External Analgesic

  • 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

    WarningsFor 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.

  • Other Information

    Distributed by CDMA., Inc.

    Novi, MI 48375

    www.qualitychoice.com

    questions: 800-935-2362

  • Packaging

    94594 QC TRIPLE ANTIBIOTIC PAIN RELIEF OINTMENT 1OZ REV05 020224 CDER

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-036
    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
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-036-011 in 1 BOX02/28/2024
    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 DrugM00402/28/2024
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)
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