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  5. Label Information: Leader Triple Antibiotic

FDA Label for Leader Triple Antibiotic

View Indications, Usage & Precautions

Table of Contents

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

Leader Triple Antibiotic Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal 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 (each gram contains)                                                                   Purpose

Bacitracin 400 units ...............................................................................................First Aid Antibiotic

Neomycin Sulfate equivalent to 3.5mg of Neomycin Base ........................................First Aid Antibiotic

Polymyxin-B Sulfate 5000 units ..............................................................................First Aid Antibiotic


Otc - Purpose



Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

  • in the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Otc - Ask Doctor



Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns


Otc - Stop Use



Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops

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


Indications & Usage



Directions

  • 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

Storage And Handling



Other information

  • store at 15 o to 25 oC (59 o to 77 oF)
  • Lot No. and Exp. Date: see box or see crimp of tube

Dosage & Administration



DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 1068808

www.myleader.com

1-800-200-6313

Made in Korea


* Please review the disclaimer below.