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  5. Label Information: Leader Oral Analgesic

FDA Label for Leader Oral Analgesic

View Indications, Usage & Precautions

Table of Contents

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

Leader Oral Analgesic 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 ingredient                                                                Purpose

Benzocaine 20%................................................................Oral Pain Reliever


Otc - Purpose



Uses

  • temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums cause by dentures or orthodontic appliances

Warnings



Warnings

Allergy alert: do not use this product if you have a history of allergic to local anesthetics such as procaine, butacaine, benzocaine, or other caine anesthetics


Otc - Do Not Use



Do not use

  • more than directed
  • for more than 7 days unless directed by a doctor/dentist

Otc - Stop Use



Stop use and ask a doctor if

  • swelling, rash, or fever develops
  • irritation, pain, or redness persists or worsens
  • symptoms do not improve in 7 days

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away


Indications & Usage



Directions

  • remove cap and cut tip of tube on score mark
  • adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentist
  • children under 12 years of age: should be supervised when using this product
  • children under 2 years of age: ask a doctor/dentist

Storage And Handling



Other information

  • store at 15o to 25oC (59o to 77oF)
  • do not use if tube tip is cut prior to opening
  • this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted
  • do not use continuously
  • Lot no and Exp. Date: see box or see crimp of tube

Inactive Ingredient



Inactive ingredients

d-sorbitol solution, flavor, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium hydrate


Dosage & Administration



DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in Korea


Package Label.Principal Display Panel



image description - 12133.1

image description - 12133.1


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