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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 August 16, 2011

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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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