Label: ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate ointment

  • NDC Code(s): 70000-0070-1
  • Packager: Cardinal Health (Leader) 70000
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 22, 2024

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  • Drug Facts

  • Active ingredients (in each gram)

    Bacitracin zinc, USP 500 units
    Polymyxin B sulfate, USP 10,000 units

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Allergy alert:

    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

    When using this product

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • a rash or other allergic reaction develops

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • clean 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 15º-25ºC (59º-77ºF)
    • Before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredient

    white petrolatum

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

    COMPARE TO POLYSPORN® active ingredients*

    Poly Bacitracin

    Bacitracin Zinc USP

    Polymyxin B Sulfate USP

    First Aid

    Antibiotic Ointment

    For External Use Only

    Help Prevent infection in Minor Cuts, Scrapes, and Burns

    *This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of Polysporin®.

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

  • Package label

    Bacitracin zinc, USP 500 units, Polymyxin B sulfate, USP 10,000 units

    LEADER Antibiotic Ointment

  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0070-11 in 1 CARTON12/31/2020
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00412/31/2020
    Labeler - Cardinal Health (Leader) 70000 (063997360)
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