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

  • NDC Code(s): 80489-012-01, 80489-012-02
  • Packager: OL PHARMA TECH, LLC
  • 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 October 2, 2023

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  • Active Ingredients

    • Bacitracin Zinc 400 units
    • Neomycin Sulfate 3.5mg
    • Polymyxin B Sulfate 5,000 units
  • Purpose

    • First aid antibiotic
  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

  • Ask a doctor

    Ask a doctor before use if you have

    • serious burns
    • deep or puncture wounds
    • animal bites
  • Stop use and ask a doctor

    Stop use and ask a doctor if

    • condition persists or gets worse
    • rash or other allergic reaction develops
  • Do not use

    • do not use in the eyes
    • do not apply over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than one week unless directed by your doctor
  • keep out of the 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 tot the surface area of the tip of a finer) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • OTHER SAFETY INFORMATION

    • store at room temperature
  • Inactive ingredient

    Petrolatum

  • Questions

    www.drspharmacyusa.com

  • Principal display panel

    Drs Triple antibiotic ointmentMaximum Strength

  • INGREDIENTS AND APPEARANCE
    DRS. PHARMACY TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80489-012-011 in 1 CARTON02/16/2021
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:80489-012-021 in 1 CARTON02/16/2021
    228.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/16/2021
    Labeler - OL PHARMA TECH, LLC (021170377)
    Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)
    Establishment
    NameAddressID/FEIBusiness Operations
    OL PHARMA TECH, LLC Drs PHARMACY021170377manufacture(80489-012)
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