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

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MEDLINE INDUSTRIES, INC.]
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NDC 53329-087-01, 53329-087-87, 53329-087-96
Set ID 301ebb9a-033b-4f04-99ff-571e921924ca
Category HUMAN OTC DRUG LABEL
Packager Medline Industries, LP
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333
  • Active Ingredient (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg (Equivalent to 3.5 mg. Neomycin)

    Polymyxin B Sulfate 5000 units

  • Purpose

    First Aid Antibiotic

    First Aid Antibiotic

    First Aid Antibiotic

  • Uses

    First aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • if you are allergic to any of the ingredients
    • 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 controlled room temperature 59°-86°F (15°-30°C).
    • use only if packaging is intact.
  • Inactive ingredients

    mineral oil, petrolatum

  • Manufacturing Information

    ®2017 Curad and Medline are registered trademarks of Medline Industries, Inc.

    Manufactured for Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093

    Made in USA of domestic and imported materials.

    1-800-633-5463

    REF: CUR001231

    RI19ULI

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-087
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'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 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-087-011 in 1 BOX01/01/2018
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:53329-087-96144 in 1 BOX01/01/2018
    2NDC:53329-087-870.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:53329-087-870.9 g in 1 PACKET; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/01/2018
    Labeler - Medline Industries, LP (025460908)