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
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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.