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  5. Label Information: Oral Analgesic Maximum Strength

FDA Label for Oral Analgesic Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. ORAL ANALGESIC (MAXIMUM STRENGTH)
    2. OTC - PURPOSE
    3. WARNINGS
    4. INDICATIONS & USAGE
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. STORAGE AND HANDLING
    9. INACTIVE INGREDIENT
    10. OTC - QUESTIONS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral Analgesic Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Lifelabs, A Division Of Atico International Usa, Inc.. 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.

Oral Analgesic (Maximum Strength)



Active Ingredient

Benzocaine 20%


Otc - Purpose



Purpose

Oral pain reliever


Uses

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


Warnings



Warnings

for temporary use only until a dentist can be consulted



Allergy alert:

do not use this product if you have a history of allergy to local anesthetics such a procaine, butacaine, benzocaine or other "caine" anesthetics.


Indications & Usage



When using this product

  • do not use more than directed
  • do not use for more than 7 days unless directed by a doctor/dentist
  • do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist

Otc - Stop Use



Stop use and ask a doctor if

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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

In cases of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



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 year of age: should be supervised in the use of this product
  • children under 2 years of age: ask a doctor/dentist

Storage And Handling



Other information

  • store at 15o to 25o (50o to 77oF)
  • 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, glycerin, peppermint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium


Otc - Questions



Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.


Package Label.Principal Display Panel









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