FDA Label for Giant Eagle Wintermint With Fluoride

View Indications, Usage & Precautions

Giant Eagle Wintermint With Fluoride Product Label

The following document was submitted to the FDA by the labeler of this product Apollo Health And Beauty Care 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% (0.01% w/v Fluoride ion)


Purpose



Anticavity


Uses



aids in the prevention of dental cavities or decay


Warnings




Keep Out Of Reach Of Children.



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


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 of rinse between your teeth for 1 minute then spit out. Do not swallow the rinse. Do not eat or dring for 30 mins after rinsing.
  • Instruct children 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



  • Cold weather may cloud this product, but will not affect its anticavity properties.
  • Store at room temperature.

Inactive Ingredients



Water (Aqua), Alcohol (21.6%), Sorbitol, Poloxamer 407, Sodium Lauryl Sulfate, Eucalyptol, Flavor, Methyl Salicylate, Thymol, Phosphoric Acid, Sucralose, Menthol, Disodium Phosphate, Red 40 (CI 16035), Blue 1 (CI 42090).


Label Copy




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