Firefly Anticavity Fluoride Rinse
FDA Label NDC 66923-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ranir Llc for the product Firefly Anticavity Fluoride (NDC 66923-003). 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 ingredient, purpose, use, keep out of reach of children., directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

Active Ingredient

Sodium Fluoride 0.05%

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities.

Keep Out Of Reach Of Children.

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

Directions

Adults and children 6 years of age and older:

use once a day after brushing your teeth with a toothpaste
vigorously swish 10 milliliters 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.

Other Information

recommended storage temperature 59°-86°F(15°-30°C)
do not use if printed plastic neckband is broken or missing

Inactive Ingredients

cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, FD&C blue#1, flavor, menthol, poloxamer 407, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose, xylitol