Label: TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate 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 December 2, 2011

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  • ACTIVE INGREDIENT

    (in each gram)

    Bacitracin zinc, USP 400 units

    Neomycin sulfate, USP 3.5 mg

    Polymyxin B sulfate, USP 5,000 units

  • PURPOSE

    First aid antibiotic

  • USES

    First aid t help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    For external  use only

    Allergy alert:

    • do not use if allergic to any of the ingredients
  • DO NOT USE

    • in the eyes
    • over large areas of the body
  • ASK DOCTOR BEFORE USE IF YOU HAVE

    • deep or puncture wounds
    • animal bites
    • serious burns
  • WHEN USING THIS PRODUCT

    • do not use longer than 1 week unless directed by a doctor
  • STOP USE AND ASK A DOCTOR IF

    • condition persists or gets worse
    • a 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 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 59º - 86ºF (15º - 30ºC).
    • Protect from freezing.
    • Before using any medication, read all label directions. Keep carton, it contains important information.
  • INACTIVE INGREDIENT

    White petrolatum

  • QUESTIONS OR COMMENTS

    1-800-632-6900

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Kroger®

    Quality Guaranteed

    Compare to the active ingredients of NEOSPORIN®.*See bottom panel.

    TRIPLE ANTIBIOTIC OINTMENT

    • Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate

    • First aid antibiotic ointment

    NET WT 1 OZ (28 g)

    01790411B1 VC110431

    4eb334a6-figure-01
    4eb334a6-figure-02

    CARTON LABEL

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  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 B SULFATE5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59450-034-311 in 1 CARTON
    128 g in 1 TUBE
    2NDC:59450-034-321 in 1 CARTON
    256 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/01/2003
    Labeler - The Kroger Co. (006999528)
    Establishment
    NameAddressID/FEIBusiness Operations
    Actavis Mid Atlantic LLC809515898MANUFACTURE(59450-034)
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