Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • Category: HUMAN OTC DRUG LABEL

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 October 1, 2012

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  • Active ingredients (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 3.5mg

    Polymyxin B Sulfate 5,000 units

    Purposes

    First 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

  • Ask a doctor before use if you have

    • serious burns
    • deep or puncture wounds
    • animal bites
  • When using this product

    • do not use in the eyes
    • do not apply over large areas of the body
  • Stop use and ask a doctor if

    • you need to use more than 1 week
    • condition persists or gets worse
    • symptoms persist for more than 1 week or clear up and occur again within a few days
    • 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

    • adults and children 2 years of age and older:
      • 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
    • children under 2 years of age: ask a doctor
  • Other information

    store at 59 degrees to 77 degrees Fahrenheit

  • Inactive ingredients

    Liquid paraffin, Cethanol, Squalane, Lanolin, Petrolatum, Tocopheryl acetate

  • Package label

    NDC NO. 53210-1004-0

    First Aid Prevent Infection

    Cuts Scrapes Burns

    Maximum Strength

    Help Prevent Infection in Minor Cuts, Scrapes and Burns

    Soothing Ointment

    Original
    TRIPLE ANTIBIOTIC
    Polymyxin B Sulfate-Bacitracin Zinc-Neomycin Sulfate

    Net 1 oz(28.3g)

    Exclusively distributed by:
    Morales Distributors, Inc
    Mayaguez, P.R. 00682

    This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Original Neosporin (R)

    Made in Korea

    carton label 1

    carton label 2

    tube label


  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC  
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53210-1004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  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 U  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    SQUALANE (UNII: GW89575KF9)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53210-1004-01 in 1 BOX
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/26/2012
    Labeler - Morales Distributors Inc. (127151731)
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