Darby Topical Fluoride Foam

Generic Name: sodium fluoride
Dosage Form: aerosol, foam

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Darby 2.72 % Topical Sodium Fluoride Foam

(1.23 % Fluoride Ions)

Mint

4.4 oz / 125 g

NDC 66467-3760-1

A topical anti-caries preparation

Directions (for professional use only):

1. Use after thorough prophylaxis

2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

Note: fill tray(s) at one quarter full to allow foam to expand

3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

4. Remove tray(s) and have patient expectorate excess

5. Advise patient not to eat, drink or rinse for 30 minutes after the application

130 applications

Medicinal ingredients:

Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)

Non-Medicinal ingredients: cocamidopropyl betaine, sodium phosphate, poloxamer 407, sucralose, xylitol, purified water, mint flavour

Warnings: KEEP OUT OF REACH OF CHILDREN

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

Do not use if seal is broken.

Rx only

Made in USA

Distributed by:

Darby Dental Supply, LLC

Jericho, Ny11753

UPC 952-9102

Rev 01