FDA Label for Fluoride Mouth Rinse Anticavity

View Indications, Usage & Precautions

Fluoride Mouth Rinse Anticavity Product Label

The following document was submitted to the FDA by the labeler of this product Target Corp.. 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 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 then spit it 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 childrenas 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



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



The ADA Council on Scientific Affairs Acceptance of up & up mint anticativity 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 product is not manufactured or distributed by Chattem, Inc., distributor of Act

Dist. by Target Corp., Mpls., MN 55403

Made in U.S.A. with U.S. and foretign components

Shop Target.com

Guest Services 1-800-910-6874

213.002/213AE rev 2


Principal Display Panel



SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ANTICAVITY

fluoride mouthrinse

*Compare to Act Anticavity Fluoride Rinse

helps prevent cavities

helps strengthen teeth

freshens breath

up & up

Mint Flavor

IMPORTANT: read directions for proper use

18 fl oz (532 mL)


* Please review the disclaimer below.