Label: TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and 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 September 28, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (each gram contains)    		Purpose
    Bacitracin zinc 500 unitsFirst aid antibiotic
    Neomycin sulfate 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
    Pramoxine HCI 10 mgExternal analgesic
  • Uses

    first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients

    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
    • condition persists for more than 7 days
    • condition clears up and occurs again 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 the 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: consult a doctor
  • Other information

    • To open: unscrew cap, pull tab to remove foil seal.
    • store at 20°-25°C (68°-77°F)
    • See carton or tube crimp for lot number and expiration date.
  • Inactive ingredient

    white petrolatum

  • Questions?

    Call 1-877-745-6888

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Phoenix Global Supply Group, Inc.
    White Plains, NY 10604

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    Triple Antibiotic
    Ointment + Pain Relief
    Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

    First Aid Antibiotic / Pain Relieving Ointment

    Maximum Strength

    NET WT 1 oz (28.4 g)

    Principal Display Panel - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52426-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES) Bacitracin Zinc500 [iU]  in 1 g
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin Sulfate3.5 mg  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate10000 [iU]  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:52426-120-051 in 1 CARTON
    114.2 g in 1 TUBE
    2NDC:52426-120-061 in 1 CARTON
    228.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B09/23/2010
    Labeler - Phoenix Global Supply Group, Inc (843189908)
    Establishment
    NameAddressID/FEIBusiness Operations
    SGS Life Science Services093840643ANALYSIS
    Establishment
    NameAddressID/FEIBusiness Operations
    Axellia Pharmaceuticals ApS305814345MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmacia and UpJohn Company829076566MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Syn-Tech Chem. & Pharm. Co., Ltd.656002532API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Axellia Pharmaceuticals AS561816174MANUFACTURE
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