Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment

  • NDC Code(s): 63868-459-05, 63868-459-10
  • Packager: Chain Drug Marketing Association
  • 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 25, 2023

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  • Drug Facts

  • Active ingredients (each gram contains)

    Bacitracin zinc 400 units
    Neomycin sulfate 3.5 mg 
    Polymyxin B sulfate 5,000 units

  • Purpose

    First Aid Antibiotic Ointment

  • 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
  • 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
  • Ask Doctor before use if you have

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
  • 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.

  • 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.

  • 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

    Inactive ingredientMineral Oil, Petrolatum

  • SPL UNCLASSIFIED SECTION

    Distributed by C.D.M.A., Inc. ©
    43157 W 9 Mile Rd.

    Novi, MI. 48375

    www.qualitychoice.com

    Questions: 800-935-2362

  • Other Information:

    This product is not manufactured or distributed by

    Johnson & Johnson Corporation, owner of the registered trademark Neosporin®

  • Packaging

    Triple Antibiotic Ointment

  • PRINCIPAL DISPLAY PANEL

    Triple Antibiotic Ointment .5oz.

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-459
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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 B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-459-101 in 1 BOX05/24/2019
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:63868-459-051 in 1 BOX03/26/2019
    214.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/26/2019
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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