Stangard Preventive Treatment Gel

Manufacturer
Pascal Company, Inc.
Effective date
2026-04-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:16:14

Label at a glance#

ProductStangard
Active ingredientSTANNOUS FLUORIDE
Label structure6 sections

Dosage and administration

Adults and children 6 years of age and older: Before dispensing, remove cap and peel off seal Use once daily after brushing with toothpaste Apply a small amount of gel totoothbrush and brush teeth thoroughly Allow the gel to remain on teeth for one minute Spit out the gel. Do not swallow. Do not eat, drink or rinse for 30 minutes after brushing Instruct children under 12 years of age in the use of this product (to...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Stannous Fluoride 0.4%

Purpose: Anticavity

Warnings:

WARNINGS SECTION

This is an anticavity preventive treatmeng gel, not a toothpaste.

Read directions carefully before using

Keep out of reach of children

If more than amount used for brushing is swallowed, seek professional assistance or contact a Poison Control Center immediately.

Do not use if foil seal is missing or damaged.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

Before dispensing, remove cap and peel off seal

Use once daily after brushing with toothpaste

Apply a small amount of gel totoothbrush and brush teeth thoroughly

Allow the gel to remain on teeth for one minute

Spit out the gel. Do not swallow.

Do not eat, drink or rinse for 30 minutes after brushing

Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without adult supervision.

Children under age 6: Consult a dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, carbomer 940, natural and artificial flavors

Other Information:

OTHER SAFETY INFORMATION

Store at 15-30°C (59-86ºF)

Keep tightly closed when not in use

Expiration Date can be found on tube crimp

StanGard

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stangard Topical Stannous Fluoride GelStangard Topical Stannous Fluoride GelStanGard Preventive Treatment Gel Mint Flavor 11-650

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10866-0271-1Stangard122 g in 1 TUBEGEL1225

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10866-027110866-0271-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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
5013b74c-2a01-6d55-e063-6294a90a28d37cae6a50-ee50-8827-e053-2991aa0a508f2026-04-22WarningsExact identifier
spl id: 5013b74c-2a01-6d55-e063-6294a90a28d3
spl set id: 7cae6a50-ee50-8827-e053-2991aa0a508f

Reported adverse events (FAERS/openFDA)#

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