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 Shopko Stores Operating., 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
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 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
Other
Sealed with printed neckband for your protection
To Open:
1. Remove Printed Tamper Evident Neckband
2. Squeeze Both tabs at Base of cap While turning the cap until loose.
To Close: Place cap back on bottle and turn cap until it clicks twice and feels secure.
This rinse may cause temporary staing to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.
*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse
Manufactured by Vi-Jon, Inc
One Swan Dr., Smyrna, TN 37167
for ShopKo Stores Operating Co., LLC
www.shopko.com
for consumer questions
call 1-888-593-0593
482.001/482AB
Principal Display Panel
ShopKo
Compare to the active ingredient of Crest*
Alcohol Free
ANTICAVITY FLUORIDE RINSE
Violet Mint
Kills bad breath germs
Helps prevent cavities
Helps strengthen enamel
Cleans teeth
Freshens breath
IMPORTANT: read directions for proper use.
33.8 FL OZ (1 L)
* Please review the disclaimer below.