FDA Label for Closys Fluoride Rinse

View Indications, Usage & Precautions

Closys Fluoride Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Rowpar Pharmaceuticals, 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.

Drug Facts




Active Ingredient



Sodium fluoride 0.05% (0.02% w/v fluoride ion)


Purpose



Anticavity


Directions



Adults and Children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour out and 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, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose


Other Information



  • do not use if safety seal is broken or missing

Packaging




* Please review the disclaimer below.