9521547 Grape Darby 60 Second Fluoride Gel 2.72% Topical Sodium Fluoride Gel

Manufacturer
Darby Dental Supply, LLC
Effective date
2018-12-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:39:03

Label at a glance#

ProductDarby Topical Sodium Fluoride
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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 SECTION

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 SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9521547 Full Label9521547 Full Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
sodium fluorideACTIVE INGREDIENT8ZYQ1474W71
fluoride ionACTIVE MOIETYQ80VPU408O1

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
66467-215066467-2150-1

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
b60bc54e-a821-122b-e053-2995a90a588dc375df5f-186e-470a-88fd-eb07dd6314e62020-12-09WarningsExact identifier
spl set id: c375df5f-186e-470a-88fd-eb07dd6314e6

Reported adverse events (FAERS/openFDA)#

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