Label at a glance#

ProductFLUORISHIELD

Active ingredientSodium Fluoride

Label structure4 sections

Dosage and administration

Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Add one drop of FluoriShield into each tooth area in the custom carrier and spread evenly with the applicator tip of the fluoride bottle. Place carriers over the teeth and let it remain in place for one (1) minute or longer (as directed by your doctor). Expectorate the excess gel. Clean carriers with cold water. Spit out the ...

Label contents#

Full prescribing information#

Inactives

INACTIVE INGREDIENT SECTION

Natrosol 250 (Hydroxyethyl Cellulose), Saccharin Sodium

Warning:

WARNINGS SECTION

PRECAUTIONS: DO NOT SWALLOW. As with all medications, keep out of reach of the children

Directions

DOSAGE & ADMINISTRATION SECTION

Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Add one drop of FluoriShield into each tooth area in the custom carrier and spread evenly with the applicator tip of the fluoride bottle. Place carriers over the teeth and let it remain in place for one (1) minute or longer (as directed by your doctor). Expectorate the excess gel. Clean carriers with cold water. Spit out the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

flourshield

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0273-8011-01	2020-01-31	C162847	48780-1	9d75b9d0-c3e5-f424-e053-dadaa90a57ce	dbba58a0-ce17-4fc0-ba81-625d78c1a9e6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0273-8011-01	FLUORISHIELD	114 g in 1 TUBE	GEL	114		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0273-8011	FLUORISHIELD (SODIUM FLUORIDE) GEL [YOUNG DENTAL MANUFACTURING I, LLC]	2	Legacy NDC, 1 package rows	20181215_dbba58a0-ce17-4fc0-ba81-625d78c1a9e6.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

FLUORISHIELD
Sodium Fluoride
Fluoride Ion
SACCHARIN SODIUM
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0273-8011	0273-8011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Fluoride	8ZYQ1474W7	ACTIM
SACCHARIN SODIUM	SB8ZUX40TY	IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	ZYD53NBL45	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
93cf110a-e80f-47c4-bf14-2d7bc0aa3bad			dbba58a0-ce17-4fc0-ba81-625d78c1a9e6	2018-12-13	Warnings	Exact identifier spl id: 93cf110a-e80f-47c4-bf14-2d7bc0aa3bad spl set id: dbba58a0-ce17-4fc0-ba81-625d78c1a9e6

Reported adverse events (FAERS/openFDA)#

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