FDA Label for Act Restoring Anticavity Fluoride Cool Mint

View Indications, Usage & Precautions

Act Restoring Anticavity Fluoride Cool Mint Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, 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 0.02% (0.009% w/v fluoride ion)


Purpose



Anticavity


Use



  • aids in the prevention of dental cavities

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
  • remove cap
  • pour 10 milliliters into cap (10 mL is equal to 2 teaspoonfuls); do not use more than 10 milliliters
  • 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 years of age: consult a dentist or doctor


Other Information



  • do not use if safety seal is broken or missing

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 (245-172)

www.actfluoride.com


Principal Display Panel



#1 DENTIST RECOMMENDED
FLUORIDE BRAND

RESTORING

Anticavity Fluoride Mouthwash
Cool Mint

33.8 fl oz. (1 L)


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