TRIPLE ANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC NEOMYCIN POLYMYXIN B SULFATE) OINTMENT [BUDPAK INC. ]

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TRIPLE ANTIBIOTIC MAXIMUM STRENGTH (BACITRACIN ZINC NEOMYCIN POLYMYXIN B SULFATE) OINTMENT [BUDPAK INC. ]
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NDC 27293-014-01, 27293-014-14
Set ID e7f5fdf0-1ce4-4f8b-af19-155690ca63be
Category HUMAN OTC DRUG LABEL
Packager Budpak Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • ACTIVE INGREDIENT

    Active Ingredients
    Bacitracin Zinc 400U
    Neomycin 3.5mg
    Polymyxin B sulfate 5000U
  • PURPOSE

    Purpose
    First Aid Antibiotic
    First Aid Antibiotic
    First Aid Antibiotic
  • INDICATIONS & USAGE

    Uses  first aid to help prevent infection in   •minor cuts   •scrapes   •burns
  • WARNINGS

    Warnings
    For external use only
  • DO NOT USE

    Do not use  •in the eyes   •if you are allergic to any of the ingredients   •longer than 1 week unless directed by a doctor   •over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use on •on deep puncture wounds, animal bites, or serious burns
  • STOP USE

    Stop use and consult a doctor if the condition persists or gets worse, or if 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 right away.
  • DOSAGE & ADMINISTRATION

    Directions
    •    Clean the affected area and dry thoroughly
    •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
  • SPL UNCLASSIFIED SECTION

    Other information
    •    Store at 68 to 77F (20C-25C)  •See carton or tube crimp for lot number and expiration date
  • INACTIVE INGREDIENT

    Inactive ingredients Petrolatum, Mineral oil, Ozocerite, Propanediol, Methylparaben, Propylparaben
  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC  MAXIMUM STRENGTH
    bacitracin zinc neomycin polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [USP'U]  in 1 g
    NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-014-011 in 1 BOX
    1NDC:27293-014-1414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/19/2011
    Labeler - Budpak Inc. (183224849)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Zhongbao Pharmaceutical Co., Ltd420795668manufacture
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