Darby

Manufacturer
Darby Dental Supply, LLC
Effective date
2020-12-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:02:37

Label at a glance#

ProductDarby Topical Sodium Fluoride Bubble Gum
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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 SECTION

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 SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9529104 Full Label9529104 Full Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
sodium fluorideACTIVE INGREDIENT8ZYQ1474W72
fluoride ionACTIVE MOIETYQ80VPU408O2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66467-373066467-3730-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b60cf07c-062d-5c79-e053-2995a90a3b460df15c84-299f-47df-bfb8-488343f280e72020-12-09WarningsExact identifier
spl id: b60cf07c-062d-5c79-e053-2995a90a3b46
spl set id: 0df15c84-299f-47df-bfb8-488343f280e7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.