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Name:Darby Topical Sodium Fluoride Grape
Manufacturer:Darby Dental Supply Co
Category:Prescription Marketed Drugs


Darby 2.72 % Topical Sodium Fluoride Foam Grape

DARBY  TOPICAL SODIUM FLUORIDE GRAPE - 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 Grape

Darby 2.72 % Topical Sodium Fluoride Foam

(1.23 % Fluoride Ions)

Grape

4.4 oz / 125 g

NDC 66467-3750-1



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, phosphoric acid, poloxamer 407, sucralose, tartaric acid, xylitol, purified water, grape 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 952-9103
Rev 00

9103foamgrape





DARBY   TOPICAL SODIUM FLUORIDE GRAPE
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-3750
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
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66467-3750-1 125 g in 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/10/2010

Labeler - Darby Dental Supply Co (825137818)

Revised: 11/2010 Darby Dental Supply Co



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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