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

  • NDC Code(s): 63868-576-01
  • Packager: Chain Drug Marketing Association 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 May 23, 2023

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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

    Warnings For 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 ingredientMineral 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 C.D.M.A., Inc.

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    questions: 800-935-2362

    Product of PRC

  • Packaging

    qc triple antibiotic plus pain 1oz

  • 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:63868-576
    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:63868-576-011 in 1 BOX06/15/2020
    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 finalpart333B06/15/2020
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)
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