FDA.reportPublic FDA data

Care One Restore and Defend

Manufacturer
Foodhold U.S.A. | Lornamead Products | Lornamead
Effective date
2025-11-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:43:35

Label at a glance#

ProductCare One Restore and Defend Sensitive Whitening
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Storage and handling

Other information products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. This product is specifically formulated to help prevent staining. store below 30°C (86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

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

OTC - PURPOSE SECTION

Purpose

Anticavity/Antihypersensitivity

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - WHEN USING SECTION

When using this product, if irritation occurs discontinue use.

OTC - STOP USE 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. If more than used for brushing is accidentally swallowed get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • Do not swallow
  • Children under 12 years of age: consult a dentist or doctor

STORAGE AND HANDLING SECTION

Other information

products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

This product is specifically formulated to help prevent staining.

  • store below 30°C (86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

OTC - QUESTIONS SECTION

Questions or Comments? CALL 1-877-846-9949

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

For product questions or concerns, contact us at 1-877-849-9949

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CareOne®

RESTORE & DEFEND SENSITIVE TOOTHPASTE

FOR SENSITIVE TEETH & CAVITY PROTECTION

DAILY PROTECTION FOR SENSITIVE TEETH

WHITENING

FRESH MINT

NET WT 3.4 OZ (96.3 g)

CareOne_RestoreDefend_Carton_2821293R1CareOne_RestoreDefend_Carton_2821293R1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN7
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD7
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY7
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY7
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-722-19Care One Restore and DefendSensitive Whitening1 in 1 CARTONPASTE, DENTIFRICE17
41520-722-19Care One Restore and DefendSensitive Whitening96.3 g in 1 TUBEPASTE, DENTIFRICE96.37

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-72241520-722-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
HYDRATED SILICAY6O7T4G8P9IACT
STANNOUS FLUORIDE3FTR44B32QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-08-12full-release2026-06-01 01:10:08

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
Care One Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEFoodhold U.S.A.81a380eb-8605-b280-e053-2a91aa0abd4b2025-11-12WarningsExact identifier
ndc (package): 41520-722-19
ndc (product): 41520-722
ndc11 (package): 41520072219
spl id: 436ba302-220c-1f0e-e063-6294a90a11ac
spl set id: 81a380eb-8605-b280-e053-2a91aa0abd4b

Reported adverse events (FAERS/openFDA)#

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