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  5. Label Information: Cvs Pharmacy Maximum Strength

FDA Label for Cvs Pharmacy Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. USES
    3. WARNINGS
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. DOSAGE & ADMINISTRATION
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cvs Pharmacy Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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.

Active Ingredient



Benzocaine 20.0% ..................................Purpose: Oral pain reliever


Uses



Temporarily relieves pain associated with the following mouth irritations toothache sore gums canker sores braces minor dental procedures


Warnings



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

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage
  • Do not use more than directed for more than 7 days unless directed by a dentist or doctor.

    • Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, irritation, pain or redness persists or worsens swelling rash or fever developes


Otc - Keep Out Of Reach Of Children



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


Directions



Adults and children 2 years of age and older:

  • apply to affect4ed area using applicator tip
  • use up to 4 times daily or as directed by a dentist or doctor. 
  • Children under 12 years of age should be supervised in the use of this product.

    • Children under 2 years of age: ask a dentist or doctor.


Other Information



Do not use if package has been opened

Store at 20-25°C (68-77°F)


Inactive Ingredients



Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, FD&C Yellow 5, Methylparaben, Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water


Dosage & Administration



Adults and children 2 years of age and older:
apply to affect4ed area using applicator tip
use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years of age should be supervised in the use of this product.
Children under 2 years of age: ask a dentist or doctor.


Package Label.Principal Display Panel



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