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  5. Label Information: Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor

FDA Label for Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (S)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRODUCT LABEL

Fraiche Stannous Fluoride Rinse, Fruit Punch Flavor Product Label

The following document was submitted to the FDA by the labeler of this product True Marker 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.

Active Ingredient (S)



Stannous fluoride, 0.63%


Purpose



Anticavity/Antigingivitis


Uses



  Aids in the prevention of dental decay

  • helps prevent gingivitis 
  • helps interfere with harmful effects of plaque associated with gingivitis.

Warnings



  • Keep out of reach of children under 6 years of age. 
  • If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away. Do not swallow.

Directions



  • Do not use before mixing with water.
  • Adults and children 6 years of age and older:
  • Use once a day after brushing your teeth with a toothpaste.
  • Open the bottle by twisting the cap counter clockwise
  • Pour 1/8 fl. oz. into a cup. Add water to line (1 fl. oz.) on cup.
  • Mix using bristle end of toothbrush
  • Vigorously swish rinse between your teeth for 1 min. and then spit out.
  • Do not swallow the rinse
  • Do not eat or drink for 30 min. after rinsing.
  • Instruct children under 12 in good rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision.
  • Children under 6: Consult a dentist or doctor.

Other Information



  • Store at room temperature 59-86˚F (15-30˚C)
  • This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Inactive Ingredients



Edetic Acid, Flavor, Glycerin, Saccharin Sodium, Xylitol


Product Label



image description - Image 801 1

image description - Image 801 1


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