Label: TRIPLE ANTIBIOTIC PLUS MAXIMUM STRENGTH- bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl 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 March 20, 2013

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  • 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)
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