DARBY TOPICAL SODIUM FLUORIDE BUBBLE GUM- sodium fluoride aerosol, foam

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 9529104 Bubble Gum

Topical Fluoride Foam

2.72% Topical Sodium Fluoride Foam

1.23% fluoride ions

4.4 oz (125 g)

NDC: 66467-3730-1

DOSAGE & ADMINISTRATION

A topical anti-caries preparation.

Directions:

1. Following prophylaxis treatment, fill 1/4 of tray with foam

2. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray

3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes

4. Remove tray and have patient expectorate excess

5. Advise patient not to eat, drink or rinse for 30 minutes after the treatment

Medicinal ingredients:

Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)

INACTIVE INGREDIENT

Non-Medicinal Ingredients: Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, bubble gum flavor

WARNINGS AND PRECAUTIONS

Warnings:

KEEP OUT OF REACH OF CHILDREN

For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104°F (40°C). Contents under pressure. Do not puncture and incinerate.

Do not use if seal is broken.

SPL UNCLASSIFIED SECTION

Made in the USA

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

UPC 9529104

Rev.02

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DARBY  TOPICAL SODIUM FLUORIDE BUBBLE GUM
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66467-3730
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 g

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-3730-1	125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/31/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/31/2012

Labeler - Darby Dental Supply, LLC (825137818)