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Darby Topical Fuoride Gel

Generic name: sodium fluoride
Dosage form: gel

Medically reviewed by Drugs.com. Last updated on Nov 23, 2020.

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 9521547 Grape

60 Second Fluoride Gel

2.72% Topical Sodium Fluoride Gel

1.23% fluoride ions

16.23 fl oz (480 ml)

NDC 66467-2150-1

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

Directions:

1. Following prophylaxis treatment, fill 1/3 of tray with gel

2. Insert tray in the patient's mouth, have patient bite down lightly for 60 seconds

3. Remove tray and have patient expectorate excess

4. 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, red 33, blue 1, saccharin sodium, titanium dioxide, 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 104°F (40°C).

Do not use if seal is broken.

Made in the USA

Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753

UPC 9521547

Rev.02

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 0.0272 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, LLC (825137818)
Darby Dental Supply, LLC

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