DARBY  TOPICAL SODIUM FLUORIDE ORANGE- sodium fluoride aerosol, foam 
Darby Dental Supply Co

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 Orange

Darby 2.72 % Topical Sodium Fluoride Foam

(1.23 % Fluoride Ions)

Orange

4.4 oz / 125 g

NDC 66467-3770-1



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, orange 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 952-9105
Rev 01

9105foamor01

DARBY   TOPICAL SODIUM FLUORIDE ORANGE
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:66467-3770
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (fluoride ion) fluoride ion.0272 g  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-3770-1125 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/31/2012
Labeler - Darby Dental Supply Co (825137818)

Revised: 11/2011
Document Id: 9b533173-ef9a-4e25-8a4a-dca65362a737
Set id: a5c7120c-0fb4-42e1-9c4f-c73d5a7e0382
Version: 2
Effective Time: 20111123
 
Darby Dental Supply Co