TRIBIOTICLC LC LC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [HART HEALTH]

TRIBIOTICLC LC LC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [HART HEALTH]
PDF | XML

NDC 50332-0031-0, 50332-0031-2
Set ID b5725d7a-2a46-415a-9b90-33dd52439217
Category HUMAN OTC DRUG LABEL
Packager HART Health
Generic Name
Product Class Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic
Product Number
Application Number PART333B
  • 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)

Related Drugs