Darby Topical Fuoride Gel

Generic Name: sodium fluoride
Dosage Form: gel

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.

Darby 60 Sec Gel 2.72 % Topical Sodium Fluoride Gel Grape

Darby 60 Sec Fluoride Gel

952-1547

2.72 % Topical Sodium Fluoride Gel

60 Second Application (1.23 % fluoride ions)

Grape

16.23 fl oz / 480mL

NDC 66467-2150-1


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, blue 1, grape 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 952-1547

Rev.00
DARBY   TOPICAL SODIUM FLUORIDE
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66467-2150
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 purple Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:66467-2150-1 480 mL in 1 BOTTLE, PLASTIC
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



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