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 Rite Aid. 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



Warning


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 for 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 milliliter 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 temperatue


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


Other



*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse
The ADA Council on Scientific affairs Acceptance of the Rite Aid Anticavity Fluoride Rinse is based on its findings the the product is effective in helping to prevent and reduce tooth decay, when used as directed

DISTRIBUTED BY:
Rite aid
30 Hunter Lane, Camp Hill, P 17011
Satisfaction Guaranteed


Principal Display Panel



Sealed With Printed Neckband for your protection

IMPORTANT READ DIRECTIONS FOR PR0POE USE

oral care

anticavity fluoride rinse mint

alcohol free

helps prevent cavities

strengthens teeth

freshens breath

ADA Accepted

American Dental Association

18 FL OZ (532 mL)


* Please review the disclaimer below.