Label: POLYSPORIN- polymyxin b sulfate and bacitracin zinc powder

  • NDC Code(s): 58232-4033-1
  • 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 May 7, 2019

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 500 unitsFirst aid antibiotic
    Polymyxin B 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 Center right away.

  • Directions

    • clean the affected area
    • apply a light dusting of the powder 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)
    • do not refrigerate
  • Inactive ingredient

    lactose base

  • Questions?

    call 1-800-223-0182

  • PRINCIPAL DISPLAY PANEL - 10g Bottle Label

    #1
    DERMATOLOGIST
    RECOMMENDED

    Polysporin®

    BACITRACIN ZINC • POLYMYXIN B SULFATE
    First Aid Antibiotic Powder

    Helps prevent infection in minor cuts, scrapes, and burns

    NET WT 0.35 oz (10g)

    Principal Display Panel - 10g Bottle Label
  • INGREDIENTS AND APPEARANCE
    POLYSPORIN 
    polymyxin b sulfate and bacitracin zinc powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-4033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58232-4033-11 in 1 CARTON06/14/201012/01/2023
    110 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B06/14/201012/01/2023
    Labeler - Johnson & Johnson Consumer Inc. (002347102)