TRIPLE ANTIBIOTIC PLUS MAXIMUM STRENGTH (BACITRACIN ZINC,NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL) OINTMENT [THE KROGER CO.]

TRIPLE ANTIBIOTIC PLUS MAXIMUM STRENGTH (BACITRACIN ZINC,NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL) OINTMENT [THE KROGER CO.]
PDF | XML

NDC 59450-823-56
Set ID 56d941b5-3b4d-44c9-b800-714a7c18f4b9
Category HUMAN OTC DRUG LABEL
Packager The Kroger Co.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • OTC - ACTIVE INGREDIENT

    (in each gram)

    Bacitracin zinc, USP 500 units

    Neomycin Sulfate, USP 3.5 mg

    Polymyxin B sulfate, USP 10,000 units

    Pramoxine hydrochloride, USP 10 mg

  • OTC - PURPOSE

    First aid antibiotic/Pain reliever

  • USES

    First aid to help prevent infection and for temporary relief of pain or discomfort due to

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    For external use only

    Allergy alert:

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

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

    • deep or puncture wounds
    • animal bites
    • serious burns[/S][/S][/S]
  • OTC - WHEN USING THIS PRODUCT

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

    • condition persists or gets worse
    • symptoms last for more than 7 days or clear up and come back within a few days
    • a rash or other allergic reaction develops
  • OTC - KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 2  DOSAGE & ADMINISTRATION

    Adults and children 2 years and older:

    • clean affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on area 1 to 3 times daily
    • may be covered with a sterile bandage

    Children under 2 years: ask a doctor

  • OTHER INFORMATION

    • Store at 59º -86ºF (15º -30ºC).
    • Before using any medication, read all label directions. Keep carton, it contains important information.
  • INACTIVE INGREDIENT

    White petrolatum

  • OTC - QUESTIONS OR COMMENTS?

    1-800-632-6900

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Kroger®

    QUALITY GUARANTEED

    Compare to the active ingredients of NEOSPORIN® PLUS.

    *See Back Panel.

    maximum strength

    TRIPLE ANTIBIOTIC OINTMENT

    PLUS PAIN RELIEF

    • Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine Hydrochloride

    • First aid antibiotic plus topical pain reliever

    NET WT 1 OZ (28 g)

    08230611xx VC108014

    268d8196-figure-01

    268d8196-figure-02

    CARTON LABEL

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC PLUS  MAXIMUM STRENGTH
    bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-823
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [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 B10000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59450-823-561 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/01/2008
    Labeler - The Kroger Co. (006999528)

Related Drugs