Label: LEADER POLY BACITRACIN- first aid antibiotic ointment

  • NDC Code(s): 70000-0093-1
  • Packager: Cardinal Health 110, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (In each gram)

    Bacitracin 500 units 

    Polymyxin B Sulfate 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

    Do not use

    • in or near the eyes
    • on large areas of the body

    Consult a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use longer than 1 week

    Stop use and consult a doctor if

    • condition persists or gets worse
    • symptoms last for more than 7 days or clear up and come back within a few days
    • a rash or other allergic reaction develops

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    • clean the affected area
    • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
    • may be covered with a sterile bandage
  • Other information

    • Store at a controlled room temperature 20º-25ºC (68° to 77°F)
  • Inactive ingredient

    Petrolatum

  • Questions? Call; 1-800-222-1087

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Carton Label

    Leader Major NDC 70000-0093-1

    Poly Bacitracin Zinc Ointment USP

    Bacitracin Zinc 500 units

    Polymixin B sulfate 10,000 units

    First Aid Antibiotic Ointment

    NET WT. 0.5 oz (14g)

    Principal Display Panel – Carton Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    Leader NDC 70000-0093-1

    Poly Bacitracin Zinc Ointment

    Bacitracin Zinc 500 Units

    Polymixin B Sulfate 10,000 units 

    First Aid Antibiotic Ointment

    Protection against Infection 

    NET WT. 0.5 oz ( 14g) 

    Principal Display Panel – Tube Label

    Principal Display Panel – Tube Label

  • INGREDIENTS AND APPEARANCE
    LEADER POLY BACITRACIN 
    first aid antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0093
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0093-11 in 1 CARTON06/01/2021
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00406/01/2021
    Labeler - Cardinal Health 110, Inc. (063997360)
    Registrant - Cardinal Health 110, Inc. (063997360)
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