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  5. Label Information: Tribiotic

FDA Label for Tribiotic

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. ADVERSE REACTIONS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tribiotic Product Label

The following document was submitted to the FDA by the labeler of this product Hart Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients (in each gram)

Bacitracin Zinc (bacitracin 400 units)

Neomycin Sulfate (neomycin 3.5mg) 

Polymyxin B Sulfate (polymyxin B 5,000 units)


Otc - Purpose



Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic


Indications & Usage



Uses: First aid to help prevent infection 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


Otc - Do Not Use



do not use

  • in or near the eyes
  • over large portions of the body
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily

Otc - Ask Doctor



Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - 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


Otc - 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. 1-800-222-1222


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


Other Information



  • avoid excessive heat
  • ointment enclosed in a sealed packet
  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)

Inactive Ingredient



White Petrolatum


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