FDA Label for Anticavity Fluoride Rinse

View Indications, Usage & Precautions

Anticavity Fluoride Rinse 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



Sodium fluoride 0.0221% (0.01% fluoride ion)


Purpose



Antcavity


Use



aids in the prevention of dental cavities


Warnings



Warnings


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 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit it out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive Ingredients



water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1


Other Information



  • store at controlled room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

Other



*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
2017 CVS/pharmacy
www.cvs.com 1-800-shop-CVS


Princpal Display Panel



CVS Health

Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash

Anticavity Fluoride Mouthwash

SODIUM FLUORIDE

6 Benefits:

  • Restores enamel
  • Helps prevent cavities
  • Cleans entire mouth
  • Kills bad breath germs
  • Strengthens teeth
  • Freshens breath
  • Eucalyptus Mint

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

    IMPORTANT: Read directions for proper use.

    1 L (33.8 FL OZ)

    163.004/163AE


* Please review the disclaimer below.