FDA Label for Anticavity
View Indications, Usage & Precautions
Anticavity Product Label
The following document was submitted to the FDA by the labeler of this product Shopko Stores Operating Co.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 0.055% (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 toothpaste
- remove cap
- pour 10 mililiters (10 mL mark on inside of cap); do not fill above thr 10 mL mark
- vigorously swish 10 mililiters 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, cetylpridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water
Other
Sealed with printed neckband for your protection.
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Bubblegum Anticavity Kids 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 1-888-593-05936
ShopKo Satisfaction Guaranteed By Refund Or Exchange
Principal Display Panel
ShopKo
Compare to the Active Ingredient of Act*
Kids Anticavity Fluoride Rinse
Bubble Gum Flavor
Strong cavity protection
Helps strengthen teeth mm1.jpg
Helps prevent cavities
Alcohol Free
IMPORTANT: read directions for proper use
18 FL OZ (532 mL)
004.001/004AE
* Please review the disclaimer below.