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


Darby 60 Sec Gel 2.72 % Topical Sodium Fluoride Gel Strawberry

DARBY  TOPICAL SODIUM FLUORIDE - sodium fluoride gel 
Darby Dental Supply Co Inc

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 60 Sec Gel 2.72 % Topical Sodium Fluoride Gel Strawberry

Darby 60 Sec Fluoride Gel

952-1541

2.72 % Topical Sodium Fluoride Gel

60 Second Application (1.23 % fluoride ions)

Strawberry

16.23 fl oz / 480mL

NDC 66467-2190-1


A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavored.

Directions:

1. Use after thorough prophylaxis

2. To dispense, fill tray(s) 1/3 with gel

3. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds

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

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

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



Non-Medicinal ingredients: Carboxy methyl cellulose, phosphoric acid, purified water, saccharin sodium (anhydrous), titanium dioxide, red 33, red 40, strawberry flavor

Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only. Do not swallow.

Not recommended for use by children under 18 months of age.

Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F.

Do not use if seal is broken.

Made in USA

Distributed by:

Darby Dental Supply, LLC

Jericho, NY 11753

UPC 952-1541

Rev.00

1541foamst

DARBY   TOPICAL SODIUM FLUORIDE
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-2190
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 mL
Product Characteristics
Color pink Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66467-2190-1 480 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/12/2010

Labeler - Darby Dental Supply Co Inc (825137818)

Revised: 11/2010 Darby Dental Supply Co Inc



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


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