Label: NEOSPORIN ORIGINAL- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

  • NDC Code(s): 58232-4002-1, 58232-4002-2, 58232-4002-6, 58232-4002-8, view more
    58232-4002-9
  • 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 September 3, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram) Purpose
    Bacitracin 400 unitsFirst aid antibiotic
    Neomycin 3.5 mgFirst aid antibiotic
    Polymyxin B 5,000 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 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 ingredients

    cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

  • Questions?

    call 1-800-223-0182

  • PRINCIPAL DISPLAY PANEL - 14.2 g Carton

    ORIGINAL OINTMENT

    NEOSPORIN®

    Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate
    FIRST AID ANTIBIOTIC OINTMENT

    NET WT 0.5 oz (14.2 g)

    PRINCIPAL DISPLAY PANEL - 14.2 g Carton
  • INGREDIENTS AND APPEARANCE
    NEOSPORIN ORIGINAL 
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-4002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  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 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COTTONSEED OIL (UNII: H3E878020N)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58232-4002-10.9 g in 1 POUCH; Type 0: Not a Combination Product08/03/201106/14/2018
    2NDC:58232-4002-21 in 1 CARTON08/03/201106/14/2018
    214.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:58232-4002-61 in 1 CARTON08/03/201107/18/2018
    328.3 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:58232-4002-9144 in 1 CARTON08/03/2011
    40.9 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:58232-4002-80.9 g in 1 POUCH; Type 0: Not a Combination Product08/03/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/03/2011
    Labeler - Johnson & Johnson Consumer Inc. (002347102)
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