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

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TRIPLE ANTIBIOTIC (BACITRACIN ZINC AND NEOMYCIN AND POLYMYXIN B SULFATE) OINTMENT [MELALEUCA, INC.]
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NDC 54473-291-01
Set ID 65ae4607-689d-6056-e053-2a91aa0aff56
Category HUMAN OTC DRUG LABEL
Packager Melaleuca, Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • ACTIVE INGREDIENT

    Active Ingredients (each gram contains:)
    Bacitracin zinc 500 units
    Neomycin 3.5 mg
    Polymyxin B sulfate 10,000 units

  • PURPOSE

    Purpose
    antibiotic

  • INDICATIONS & USAGE

    Uses
    First aid to help prevent the risk of infection in minor

    • cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings
    For external use only.

  • DO NOT USE

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than one week unless directed by a doctor
  • ASK DOCTOR

    Ask a doctor
    before use     in case of deep or puncture wounds, animal bites, or serious burns

  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    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 1-3 times daily
    • may be covered with a sterile bandage
  • INACTIVE INGREDIENT

    Inactive ingredients:  Melaleuca Oil (T36-C5 (R)), mineral oil, petrolatum

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc and neomycin and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-291
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 U  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 U  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-291-0114 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/01/1995
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.079711683manufacture(54473-291)
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