Nafrinse Unit Dose Bubble Gum
FDA Label NDC 0273-8003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Young Dental Manufacturing Co 1, Llc. for the product Nafrinse Unit Dose Bubble Gum (NDC 0273-8003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, inactives, purpose, warning:, dosage and administration:, keep out of reach of children, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

Bubble 5 (Bubble Gum 5)

Bubble 5 (Bubble Gum 5)

Bubble 10 (Bubble 10)

Bubble 10 (Bubble 10)

Mint (Mint)

Mint (Mint)

Very Berry (Very Berry)

Very Berry (Very Berry)

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