DARBY TOPICAL SODIUM FLUORIDE- sodium fluoride gel

Darby by

Drug Labeling and Warnings

Darby by is a Prescription medication manufactured, distributed, or labeled by Darby Dental Supply, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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

DOSAGE & ADMINISTRATION

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)

INACTIVE INGREDIENT

Non-Medicinal Ingredients: Carboxy methyl cellulose, phosphoric acid, purified water, red 33, blue 1, saccharin sodium, titanium dioxide, grape flavor

WARNINGS AND PRECAUTIONS

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.

SPL UNCLASSIFIED SECTION

Made in the USA

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

UPC 9521547

Rev.02

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DARBY  TOPICAL SODIUM FLUORIDE
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66467-2150
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	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	Marketing Start Date	Marketing End Date
1	NDC: 66467-2150-1	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/12/2010

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)