Darby Topical Fluoride Foam

Generic Name: sodium fluoride

Dosage Form: aerosol, foam
DARBY 2.72 % Topical Sodium Fluoride Foam Mint

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

DARBY   TOPICAL SODIUM FLUORIDE MINT sodium fluoride  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-3760 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) fluoride ion .0272 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66467-3760-1 125 g In 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/31/2012

Labeler - Darby Dental Supply Co (825137818)

Revised: 11/2011Darby Dental Supply Co