TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MORALES DISTRIBUTORS INC.]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MORALES DISTRIBUTORS INC.]
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NDC 53210-1004-0
Set ID c3f80241-58ec-4608-8807-482ba8c91eef
Category HUMAN OTC DRUG LABEL
Packager Morales Distributors Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • 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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