FDA Label for Kids Flouride Rinse
View Indications, Usage & Precautions
Kids Flouride Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, 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 0.05% (0.02% w/v fluoride ion)
Purpose
Anticavity rinse
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, 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 millilters (10 mL mark on inside of cap); do not fill above 10 mL mark
- vigourously 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
Other Information
• store at room temperature
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
Questions?
Or to report an adverse event call 800-824-1706
Monday - Friday 9am - 4pm MST
Other
"The ADA Council on Scientific Affairs' Acceptance of WinCo Food Anticavity Fluoride Rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed."
*This is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Kids Fluoride Rinse.
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
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SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Compare to the active ingredients in ACT Anticavity Kids Fluoride Rinse*
WinCo Foods
ANTICAVITY Fluoride Rinse
Strong Cavity Protection
Alcohol Free
Helps Strengthen Teeth
ADA Accepted American Dental Association
Bubble Gum Flavor
18 FL OZ (532 mL)
IMPORTANT: READ DIRECTIONS FOR PROPER USE.
004.001/004AE
* Please review the disclaimer below.