FDA.reportPublic FDA data

Rexall Restore and Defend Sensitive Whitening

Manufacturer
Old East Main CO. | Ashtel Studios Inc.
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:25:46

Label at a glance#

ProductRexall Restore and Defend Sensitive Whitening
Active ingredientSTANNOUS FLUORIDE
Label structure9 sections

Indications and uses

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact • aids in the prevention of dental cavities

Dosage and administration

• ​Adult and children 12 years & older: ​apply at least a 1-inch strip of the product onto a soft bristle toothbrush • brush teeth thoroughly for at least one minute, twice a day (morning and evening) and not more than 3 times a day or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. • minimize swallowing. Spit out after brushing. •  ​Children under 12 years of age:  ​...

Storage and handling

Products containing stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. Store at room temperature 68-77°F (20-25°C)

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.454%
(0.15% w/v Fluoride ion)

​Purpose

OTC - PURPOSE SECTION

Anticavity, Antihypersensitivity

Uses

INDICATIONS & USAGE SECTION

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact • aids in the prevention of dental cavities

​Warnings

WARNINGS SECTION

​Stop use and ask a dentist if • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• ​Keep out of reach of children under 12 years of age. ​If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

​Directions

DOSAGE & ADMINISTRATION SECTION

• ​Adult and children 12 years & older: ​apply at least a 1-inch strip of the product onto a soft bristle toothbrush • brush teeth thoroughly for at least one minute, twice a day (morning and evening) and not more than 3 times a day or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. • minimize swallowing. Spit out after brushing. • ​Children under 12 years of age: ​Consult a dentist or doctor.

​Other information

STORAGE AND HANDLING SECTION

Products containing stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. Store at room temperature 68-77°F (20-25°C)

​Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, treated water, PEG-8, PEG-32, sodium lauryl sulphate, tetrasodium pyrophosphate, flavor, trisodium phosphate, titanium dioxide, cocamidopropyl betaine, sodium saccharin, xanthan gum, polyacrylic acid, benzyl alcohol

SPL UNCLASSIFIED SECTION

​Since 1903​

TOOTHPASTE WITH FLUORIDE

• For sensitive teeth and cavity protection
• Great for everyday use

​Brushing twice a day with Rexall​™​ Restore & Defend Sensitive Toothpaste helps repair sensitive teeth and protect against painful sensitivity.

• Provides daily relief & protection for sensitive teeth*
• Contains fluoride for cavity protection
• Removes stains for whiter teeth
• Freshens breath

​100% Satisfaction Guaranteed!
(888) 309-9030

*With brushing twice daily

DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

PRODUCT OF INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN2
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD2
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-820-012024-10-15C16284748780-11030e365-51cb-111a-e063-dadaa90a10e2Rexall ​™ ​SENSITIVE TOOTHPASTE WITH FLUORIDE - WHITENING
55910-820-012024-01-30C16284748780-11030e365-51cb-111a-e063-dadaa90a10e2Rexall ​™ ​SENSITIVE TOOTHPASTE WITH FLUORIDE - WHITENING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-820-01Rexall Restore and Defend Sensitive Whitening96.4 g in 1 TUBEPASTE, DENTIFRICE96.42
55910-820-01Rexall Restore and Defend Sensitive Whitening1 in 1 BOXPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-820REXALL RESTORE AND DEFEND SENSITIVE WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [OLD EAST MAIN CO.]2Current NDC, Legacy NDC, 2 package rows20241017_691c9638-75d2-4e53-bec4-2eafacd7216c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-82055910-820-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEB70850QPHRIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
BENZYL ALCOHOLLKG8494WBHIACT

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
Rexall Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEOld East Main CO.691c9638-75d2-4e53-bec4-2eafacd7216c2024-10-14WarningsExact identifier
ndc (package): 55910-820-01
ndc (product): 55910-820
ndc11 (package): 55910082001
spl id: 513e53d3-ae6a-4030-8052-e7b7b6ba32b3
spl set id: 691c9638-75d2-4e53-bec4-2eafacd7216c

Reported adverse events (FAERS/openFDA)#

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