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 Consumer Product Partners, 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.
Claims
KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE
Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Purpose
Anticavity rinse
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 accidentaly swallowed, seek professional assistance or contact a Poison Control Center immediately.
Directions
- adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
- remove cap
- pour 10 milliliters (10 mL mark on inside of cap):do not fill above the 10 mL mark
- vigorously swish 10 milliliters 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
benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water
Other Information
- store at room temperature
Disclaimer
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ® Bubblegum Blowout Anticavity Fluoride Rinse.
Adverse Reaction
Distributed by: Vi-Jon, LLC, One Swan Drive, Smyrna, TN 37167
Principal Display Panel
Sealed With Printed Neckband For Your Protection
SWAN
KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE
bubble gum FLAVOR
Strong Cavity Protection
Compare to the active ingredient of Act ®Bubblegum Blowout Anticavity Fluoride Rinse*
IMPORTANT:READ DIRECTIONS FOR PROPER USE
18 FL OZ (532 mL)
* Please review the disclaimer below.