FDA Label for Alcohol-free Anticavity

View Indications, Usage & Precautions

Alcohol-free Anticavity Product Label

The following document was submitted to the FDA by the labeler of this product Retail Business Services, 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.

Tep



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Active Ingredients



Sodium fluoride 0.02% (0.0 1% w/v fluoride ion)


Purpose



Anticavity


Use



aids in the prevention of dental cavities


Warning



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 between your teeth for 1 minute and 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 without supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive Ingredients



water, glycerin, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3


Claims



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


Dislcaimer



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

482.001/482AB


Adverse Reaction



DISTRIBUTED BY:

FODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949


Principal Display Panel



Compare to the Active Ingredient in Crest Pro-Health Advanced Anticavity Fluoride Mouthwash

CAREONE

ALCOHOL FREE FLUORIDE

MOUTH

WASH

ANTICAVITY FLUORIDE RINSE

VIOLET MINT FLAVOR

Kills Bad Breath Germs

Helps Prevent Cavities

Helps Strengthen Enamel

Cleans Teeth

Freshens Breath

1 LITER

(3.8 FL OZ)

IMPORTANT: Read directions for proper use


* Please review the disclaimer below.