FDA Label for Anticavity Rinse

View Indications, Usage & Precautions

Anticavity Rinse 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.

Active Ingredient



Sodium Fluoride 0.05% (0.2% w/v fluoride ion)        


Purpose



Anticavity Rinse


Use



aids in the prevention of dental cavities


Warnings



for this product


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 year of age and older: use once a day after 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 milliliters 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 year of age: consult a dentist or doctor

Other Information



store at room temperature


Inactive Ingredients



benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxomer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water


Adverse Reactions Section



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

Distributed by Demoulas Super Markets, Inc.

875 East Street, Tewksbuty, MA 01876

004.002/004AE


Principal Display Panel



Sealed with printed neckband for your protection

MORE FOR YOUR DOLLAR

MARKET BASKET

ANTI-CAVITY

Compare to Act

Bubble Gum Flavor

FLUORIDE RINSE

  • Alcohol Free
  • Strong Cavity Protection
  • Helps Strengthen teeth
  • Freshen breath
  • IMPORTANT: read directions for proper use

    18 FL OZ (532 mL)


* Please review the disclaimer below.