Label: TRIPLE ANTIBIOTIC WITH PAIN RELIEF MAXIMUM STRENGTH- bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride 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 27, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (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

  • Purposes

    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

    Do not use

    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    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

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age 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 the area 1 to 3 times daily
    • may be covered with a sterile bandage

    Children under 2 years of age: ask a doctor

  • Other information

    • Store at 59° - 86°F (15° - 30°C).
    • Before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredient

    white petrolatum

  • PRINCIPAL DISPLAY PANEL

    Well at Walgreens
    WALGREENS PHARMACIST RECOMMENDED
    MAXIMUM STRENGTH
    Triple Antibiotic with Pain Relief
    Bacitracin Zinc /Neomycin Sulfate / Polymyxin B Sulfate /Pramoxine HCI

    • First aid antibiotic
    • Pain relieving ointment

    Compare to Neosporin® +
    Pain Relief active ingredients
    Helps prevent infection & relieves pain in minor cuts, scrapes & burns

    NET WT 0.5 OZ (14 g)

    walgreens triple with pain relief label1
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC WITH PAIN RELIEF  MAXIMUM STRENGTH
    bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0123
    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:0363-0123-011 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B03/27/2014
    Labeler - Walgreen Company (008965063)
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