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 Liberty Procurement, Inc. 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
Warning
for this product only
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 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
- vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
- do now 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 necessay 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
water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5
Ada Council Statement
"The ADA Council on Scientific Affairs Acceptance of Core Values Mint Anticavity Fluoride Rinse is based on its finding that the product is effective in helpting to prevent and reduce tooth decay, when used as directed."
Disclaimer
This product is not manufactured or distributed by Chattem, Inc., distributor of Act
Adverse Reactions
Distributed by
Liberty Procurement, Inc
650 Liberty Ave.
Union, NJ 07083 USA
Visit us at: 222.facevalues.com
SATISFACTION GUARANTEED
Or Your
Money Back
213.002/213AE Rev 2
Principal Display Panel
Sealed with printed neckband for your protection
COREVALUES
Compare to the active ingredient in Act
Anticavity
FLUORIDE
RINSE
- Helps prevent cavities
- Helps strengthen teeth
- Freshens Breath
Mint Flavor
ADA
Accepted
American Dental Association
IMPORTANT: Read directions for proper use
18 FL OZ ( 1 PT 2 FL OZ) 532 mL
* Please review the disclaimer below.