FDA Label for Sodium Fluoride

View Indications, Usage & Precautions

Sodium Fluoride Product Label

The following document was submitted to the FDA by the labeler of this product Demoulas Super Markets, 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.

Claims



Leaves your entire mouth feeling clean while it helps strengthen teeth and prevent tooth decay.


Active Ingredient



Sodium fluoride 0.02% (0.009% w/v fluoride ion)


Purpose



Anticavity


Use



Aids in the prevention of dental cavities


Warning



for this product


Keep Out Of Reach Of Children.



If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) 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

Inactive Ingredients



water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1


Adverse Reaction



*This  product is not manufactured or distributed by Chattem Inc., distributor of Act Restoring Anticavity Mouthwash Cool Mint

Like it or let us make it right.

DSP-TN-21091

DSP-MO-20087

DISTRIBUTED BY 

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET

TEWKSBURY, MA 01876


Principal Panel Display



Sealed With Printed Neckband For Your Proection

MARKET BASKET

"MORE FOR YOUR DOLLAR"

compare to Act Restoring Anticavity Fluoride Mouthwash*

Restoring Anticavity Fluoride Mouthwash

ANTICAVITY MOUTHWASH

Restores enamel

Helps avoid tooth decay

Helps remineralize soft spots

Freshens breath

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 L)


* Please review the disclaimer below.