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

  • NDC Code(s): 69968-0612-1
  • 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 January 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

    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 one 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 equals 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° - 77° F)
  • Inactive ingredients

    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 - 14.2 g Tube Carton

    #1 DOCTOR
    RECOMMENDED
    BRAND

    SIMPLY

    NEOSPORIN™

    MADE WITH ONLY

    3 INGREDIENTS

    Strong Infection
    Protection

    No Sting Formula

    free from
    Parabens

    free from
    Preservatives

    free from
    Neomycin

    OINTMENT

    FIRST AID ANTIBIOTIC OINTMENT

    Bacitracin Zinc - Polymyxin B Sulfate

    NET WT. 0.5 OZ (14.2 g)

    PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SIMPLY NEOSPORIN   FIRST AID ANTIBIOTIC
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0612
    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:69968-0612-11 in 1 CARTON02/24/2020
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/24/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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