Darby Topical Fuoride Gel

Generic Name: sodium fluoride

Dosage Form: gel
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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color purple Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66467-2150-1 480 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: 11/2010Darby Dental Supply Co Inc

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• Prevention of Dental Caries