FDA Label for Nafrinse Unit Dose Bubble Gum

View Indications, Usage & Precautions

Nafrinse Unit Dose Bubble Gum Product Label

The following document was submitted to the FDA by the labeler of this product Young Dental Manufacturing Co 1, Llc.. 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 Ingredients



Sodium Fluoride


Inactives



Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring

Dye ( Only present in Mint and Very Berry flavors)


Purpose



Prevention of dental caries.


Warning:



a) Do not swallow b) Do not eat, drink or rinse with water for 30 minutes after use. c) Instruct children under 12 years of age in the use of the product and in good brushing and rinsing habits to minimize swallowing d) Not recommended for use in children younger than 6 years of age.


Dosage And Administration:



DIRECTIONS FOR USE: {Best Results • Use Early Morning)

1. Each pupil receives one cup and one napkin. 2. Have the pupils remove the lids from the cups. 3. Have the pupils empty the contents of the cup into their mouths and swish thoroughly for one minute. 4. HOLD CUP AGAINST THE MOUTH. Spit solution back into the cup. 5. Have the pupils wipe their mouths with the napkin; then stuff the napkin slowly into the cup to absorb the solution. 6. Discard the cup with the napkin into the provided trash bag. a) Do not swallow b) Do not eat, drink or rinse with water for 30 minutes after use. c) Instruct children under 12 years of age in the use of the product and in good brushing and rinsing habits to minimize swallowing d) Not recommended for use in children younger than 6 years of age. ADDITIONAL INSTRUCTIONS/IMPORTANT: In order to avoid spillage of the solution from the cup, the children must be instructed to do the following: 1) When spitting the fluoride solution from the mouth back into the cup, the children must hold the cup close to the mouth, and spit slowly into the cup. 2) The napkins must be stuffed into the cups very slowly in order to avoid spillage.


Keep Out Of Reach Of Children



Keep out of reach of children


Product Label




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