DARBY TOPICAL SODIUM FLUORIDE CHERRY- sodium fluoride aerosol, foam 
Darby Dental Supply, LLC

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.

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Darby 2.72 % Topical Sodium Fluoride Foam Cherry

Darby 2.72 % Topical Sodium Fluoride Foam

(1.23 % Fluoride Ions)

Cherry

4.4 oz / 125 g

NDC 66467-3740-1

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, cherry 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 952-9106

Rev 01

9106foamch01

DARBY  TOPICAL SODIUM FLUORIDE CHERRY
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-3740
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-3740-1125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/31/201211/24/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/31/201211/24/2014
Labeler - Darby Dental Supply, LLC (825137818)

Revised: 4/2017
 
Darby Dental Supply, LLC