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

  • NDC Code(s): 46122-414-03, 46122-414-05
  • Packager: AmerisourceBergen
  • 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 July 13, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin zinc USP 400 unitsFirst aid antibiotic
    Neomycin sulfate USP 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate USP 5,000 unitsFirst aid antibiotic
  • Uses

    first aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    Do not use

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

    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
    • 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

    • 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
  • Other information

    • store at 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed By AmerisourceBergen
    1300 Morris Drive, Chesterbrook, PA 19087

  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    Compare to the active ingredients in Neosporin®*
    NDC 46122-414-05

    Rx
    GOOD
    NEIGHBOR
    PHARMACY®

    Triple Antibiotic Ointment

    Bacitracin Zinc USP • Neomycin Sulfate USP • Polymyxin B Sulfate USP

    First Aid Antibiotic Ointment

    NET WT ½ oz (14.2 g)

    PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [iU]  in 1 g
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin Sulfate3.5 mg  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    cocoa butter (UNII: 512OYT1CRR)  
    cottonseed oil (UNII: H3E878020N)  
    olive oil (UNII: 6UYK2W1W1E)  
    sodium pyruvate (UNII: POD38AIF08)  
    .alpha.-tocopherol (UNII: H4N855PNZ1)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-414-051 in 1 CARTON04/04/2017
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:46122-414-031 in 1 CARTON04/04/2017
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B12/15/2015
    Labeler - AmerisourceBergen (007914906)
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