Label: TRIBIOTICLC LC LC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine 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 October 18, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg (equivalent to 3.5mg neomycin base)

    Polymyxin B Sulfate 5,000 units

    Lidocaine 40mg

  • PURPOSE

    Purpose:

    Topical Antibiotic

    Topical Antibiotic

    Topical Antibiotic

    Topical Anesthetic

  • INDICATIONS & USAGE

    Uses: First aid to help prevent infection and temporarily relieve pain in
    • minor cuts
    • scrapes
    • burns
    • abrasions
  • WARNINGS

    Warnings: For external use only

    Serious burns require immediate medical attention


  • ADVERSE REACTIONS

    Allergy alert: Do not use if you are allergic to any of the ingredients

  • DO NOT USE

    do not use
    • in or near the eyes
    • over large portions of the body
    • in large quantities, particularly over raw surfaces or blistered areas
    • longer than 7 days unless directed by a doctor
    • more than 1 to 3 times daily
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if
    • condition worsens or lasts for more than 7 days
    • a rash or other allergic reaction occurs
    • symptoms clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions:

    Do not use more than directed.

    Adults and children 12 years of age and over:

    • clean the affected area
    • apply 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 12 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Petrolatum

  • PRINCIPAL DISPLAY PANEL

    tribioticlc.jpgtribioticlc.jpg

  • INGREDIENTS AND APPEARANCE
    TRIBIOTICLC LC   LC
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400   in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000   in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0031-225 in 1 BOX, UNIT-DOSE
    1NDC:50332-0031-0.5 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/04/2012
    Labeler - HART Health (069560969)
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