Label: BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 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 September 8, 2017

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  • ACTIVE INGREDIENT

    Active ingredient (in ea. gram)                                                Purpose           
    Bacitracin Zinc 400 Units                                                          First Aid Antibiotic

    Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)              First Aid Antibiotic

    Polymyxin B Sulfate 5000 Units                                                 First Aid Antibiotic

  • Ask a doctor before use:

    First aid to help prevent infection in:

    • Minor cuts
    • scrapes
    • burns
  • Purpose

    First aid to help prevent infection in:

    • Minor cuts
    • scrapes
    • burns
  • Other information

    • store at controlled room temperature 15°-30° C (59°-86° F)
    • avoid excessive heat and humidity
  • Inactive ingredients:

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • Keep Out Of Reach Of Children

    KEEP OUT OF REACH OF CHILDREN

  • Warnings

    For external use only

  • Dosage and Administration

    • clean the affected areas
    • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • Do Not Use:

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor
  • Stop use and ask a doctor if

    • Stop use and ask a doctor if condition persists or gets worse, or if a rash or other allergic reaction occurs
  • PRINCIPAL DISPLAY PANEL - 15 g Tube Box Label

    Austin/Travis Co. Health & Human Services Dept.
    1000 Toyath St. Austin, TX 78702 512-972-6206

    Triple
    Antibiotic
    Oint #15g

    Date:

    Name:
    Dr.

    USE AS DIRECTED

    10/2018

    HW15015

    Triple Antibiotic Ointment #15 g NDC 76413-347-01

    Batch: 08311701
    Lot: HW15015
    Exp: 10/2018
    Dynarex

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    Principal Display Panel - 15 g Tube Box Label
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
    bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-347(NDC:67777-217)
    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) NEOMYCIN5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76413-347-011 in 1 BOX04/18/2016
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2009
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK(76413-347) , RELABEL(76413-347)
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