FDA Label for Act Kids Anticavity Fluoride Wild Watermelon

View Indications, Usage & Precautions

Act Kids Anticavity Fluoride Wild Watermelon 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 0.05% (0.02% 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 accidently swallowed, get medical help or contact Poison Control Center right away.


Directions



adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • remove cap
  • hold bottle upright and squeeze. Fill to FILL LINE
  • pour out. Only the correct 10 milliliters dose will pour out
  • 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



  • contains FD&C yellow no.5 (tartrazine) as a color additive
  • do not use if safety seal is broken or missing

Inactive Ingredients



calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5 (309-023)


Principal Display Panel



ACT Kids
Anticavity Fluoride Rinse
 Wild Watermelon
Sodium Fluoride 0.05%
16.9 fl oz (500 mL)


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