Label: POLYSPORIN FIRST AID ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment

  • NDC Code(s): 69968-0060-1, 69968-0060-2, 69968-0060-3, 69968-0060-9
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 December 1, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin Zinc 500 unitsFirst aid antibiotic
    Polymyxin B Sulfate 10,000 unitsFirst aid antibiotic
  • Use

    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 Centre 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)
  • Inactive ingredient

    petrolatum

  • Questions?

    call 800-223-0182 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton

    #1 Dermatologist Recommended
    for Infection Protection

    Helps prevent infection in
    minor cuts, scrapes, and burns
    #1

    DERMATOLOGIST
    RECOMMENDED

    Polysporin®
    BACITRACIN ZINC • POLYMYXIN B SULFATE
    NET WT 1 oz (28.3 g) First Aid Antibiotic Ointment

    PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    POLYSPORIN FIRST AID ANTIBIOTIC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0060
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0060-21 in 1 CARTON07/09/2013
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69968-0060-10.9 g in 1 PACKET; Type 0: Not a Combination Product07/09/2013
    3NDC:69968-0060-31 in 1 CARTON07/09/2013
    314.2 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:69968-0060-9144 in 1 CARTON07/09/2013
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B07/09/2013
    Labeler - Johnson & Johnson Consumer Inc. (002347102)