FDA Label for Oral Antivavity

View Indications, Usage & Precautions

Oral Antivavity Product Label

The following document was submitted to the FDA by the labeler of this product Harris Teeter, Llc. 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 0.02% (0.01% w/v fluoride ion)


Purpose



Anticavity


Use



aids in the prevention of dental cavities


Warnings



For this product


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 bwtween your teeth for 1 minute then spit 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 witout supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive Ingredients



water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1


Questions?



Call 1-888-593-0593


Claims



This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Proctor and Gamble, distributer of Crest Pro-Health Advanced Anticavity Fluoride Mouthwash. 


Adverse Reactions



PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com


Principal Display Panel



Harris Teeter

Sealed with printed neckband for your protection

Compare to Crest Pro-Health Advanced*

Refreshing Mint

Fluoride

Alcohol Free

Mouth Rinse

Anticavity Mouthwash

  • KILLS GERMS THAT CAUSE BAD BREATH
  • HELPS PREVENT CAVITIES
  • IMPORTANT: READ DIRECTINS FOR PROPER USE

    1 L (1.05 qt) 33.8 FL OZ


* Please review the disclaimer below.