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 Wal-mart Stores, 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.

Claims



Alcohol Free

Anticavity

Oral Rinse

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


Safety Seal



Sealed with printed neckband for your protection


Active Ingredient



Sodium fluoride 0.0219% (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, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, blue 1


Questions?



Call 1-888-287-1915


Satisfaction



Satisfaction guaranteed-Or wel'll replace it or give you your money back.  For questions or comments or to report an undesired reaction or side

effect, pleace call 1-888-287-1915


Adverse Reactions



Distributed by: Wal-Mart Stores, Inc., Bentonville, Ar 72716

576.000/576AB


Disclaimer



This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride rinse.


Principal Display Panel



equate

Compare to Crest Pro Health Anticavity Fluoride Rinse

IMPORTANT: READ DIRECTINS FOR PROPER USE

Alcohol Free

Anticavity

Oral Rinse

Multi-Action with Fluoride

* Please review the disclaimer below.