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Darby

Darby Dental Supply Co Inc

Darby 60 Sec Gel 2.72 % Topical Sodium Fluoride Gel Mint




FULL PRESCRIBING INFORMATION

Darby 60 Sec Fluoride Gel

952-1530

2.72 % Topical Sodium Fluoride Gel

60 Second Application (1.23 % fluoride ions)

Mint

16.23 fl oz / 480mL

NDC 66467-2160-1


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, blue 1, yellow 5, peppermint oil, spearmint oil.

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.

Made in USA

Distributed by:

Darby Dental Supply, LLC

Jericho, NY 11753

UPC 952-1530

Darby

Darby

Sodium Fluoride GEL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:66467-2160
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION .0272 g

Product Characteristics

Color
green

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66467-2160-1 480 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-11-18


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Be sure to consult your doctor before taking any medication!
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