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 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


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 the 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

The ADA Council on Scientfic Affairs Acceptance of Harmon Face Values Kids Anticavity Fluoride Rinse is based on its finding that the product is effective n helping to prevent and reduce tooth decay, when used as directed.

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse.

Dist. by Harmon Stores, Inc.

650 Liberty Ave.

Union, NJ 07083 USA

Harmon stores, Inc.

Visit us at: www.facevalues.com


Principal Display Panel



HARMON FACEVALUES

Compare Ours to the Active Ingredient of ACT Anticavity Fluoride Rinse*

KIDS ANTICAVITY FLUORIDE RINSE

BUBBLE GUM FLAVOR

Strong Cavity Protection

Helps Strengthen Teeth

IMPORTANT: Read directins for proper use.

ADA Accepted American Dental Associatinon

18 FL OZ (1 PT 2 FL OZ) 532 mL


* Please review the disclaimer below.