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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. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. DIRECTIONS
    5. OTC - QUESTIONS
    6. 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 Meijer Distribution 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.

Otc - Active Ingredient



Active Ingredients          PurposeBenzocaine20%                  Oral pain relieverMenthol 0.25%                    Oral pain reliever

Otc - Purpose



Use     for the temporary relief of pain due to:

canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances


Warnings



Allergy Alert
do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzcaine or other "caine" anesthetics

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

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

Keep out of reach of children
in case of overdose, get medical help or contact a Poison Control Center right away



Directions



Directions   

remove cap and cut tip of the tube on score mark
adults and children 2 years of age and over:  apply to tyhe affected area up to 4 times daily or as directed by doctor/dentist
children under 12 years of age: should be supervised in the use of this product
Children under 2 years of age:  ask a doctor/dentist

Other information

Do not use if tube tip is cut prior to opening.

Inactive ingredients cellulose gum, gelatin, methyl salicylate, pectin, plasticized hydrdocarbon gel, polyethylene glycol, sodium saccharin

Otc - Questions



Questions or comments?  call us at 1-800-952-5080 M-F 9am-5pm


Package Label.Principal Display Panel



MeijerOral Analgesic Pastemaximum strengthFor Fast Relief of Oral Pain Caused by:Toothache, Denture, or Gum Irritations,Cold or Canker soresOral Analgesic Pastemaximum strengthsafety sealed tube tipMET WT. 0.21 oz (6g)carton image

* Please review the disclaimer below.