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  5. Label Information: Sore Mouth Cleanser

FDA Label for Sore Mouth Cleanser

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. DISCLAIMER
    12. ADVERSE REACTIONS
    13. PRINCIPAL DISPLAY PANEL

Sore Mouth Cleanser Product Label

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

Active Ingredient



Hydrogen peroxide 150 mg/10mL


Purpose



Oral debriding agent/Oral wound cleanser


Uses



  • aids in the removal of phlgem, mucus, or other secretions associated with occasional sore mouth
  • for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, acidental injury, or other irritations of the mouth and gums
  • for temporary use to cleanse canker sores
  • assists in the removal of foreign material from minor oral wounds

Warnings



For this product


Do Not Use



this product for more than 7 days unless directed by a dentist or doctor.  If sore mouth symptoms do not improve in 7 days: if irritation, pain, or redenss persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly


When Using This Product



do not swallow


Keep Out Of Reach Of Children



If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away


Directions



  • adults and children 2 years of age and older: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
  • children under 12 should be supervised in the use of the product
  • children under 2 years of age: consult a dentist or doctor

Other Information



store at controlled room temperature 68-77°F (20-25°C)


Inactive Ingredients



water, sorbitol, propylene glcol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, blue 1


Disclaimer



This product is not manufactured or distributed by Colgate Oral Pharmaceuticals, distributor of Colgate Peroxyl Mouth Sore Rinse Alcohol-Free Mild Mint


Adverse Reactions



Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2015 CVS/Pharmacy

CVS.com  1-800-shop CVS

Made in the U.S.A. with U.S. and Foreign Parts

CVS Quality

Money Back Guarantee

Please Recycle

462.002/462AA rev 1


Principal Display Panel



CVS

Health

Compare to the active ingredient in Colgate Peroxyl Oral Cleanser

Alcohol Free

Peroxide Sore

Mouth Cleanser

HYDROGEN PEROXIDE 1.5%

  • Oral debriding agent
  • Oral antiseptic
  • Helps reduce bacteria to promote better oral health

    • Soothing Mint

    Sealed with printed neckband for your protection. Do not use if broken or missing.

    8 FL OZ (236 mL)

    image description - mm2

    image description - mm2


* Please review the disclaimer below.