FDA.reportPublic FDA data

Trader Joes

Manufacturer
TRADER JOE'S COMPANY
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:38:17

Label at a glance#

ProductTrader Joes
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure8 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

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 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

  • Potassium Nitrate .......... 5%
  • Sodium Fluoride ............ 0.24%

Purposes

OTC - PURPOSE SECTION

  • Anti-hypersensitivity
  • Anticavity

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 contact a dentist if

OTC - STOP USE SECTION

  • 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control
Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 1 minute twice a day (morning

and evening), and not more than 3 times a day, or as recommended
by a dentist or doctor. 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

OTHER SAFETY INFORMATION

  • do not use above 25°C (77°F)
  • do not use if seal under cap is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Hydrated Silica, Sorbitol, Glycerin, Xylitol, Xanthan Gum, Natural Flavor, Cocamidopropyl Betaine, Sodium
Cocoyl Glutamate, Stevia Rebaudiana Extract, Mentha Piperita (Peppermint) Oil.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN2
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD2
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71270-110-06Trader Joes170 g in 1 TUBEPASTE1702

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71270-11071270-110-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PEPPERMINT OILAV092KU4JHIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
XYLITOLVCQ006KQ1EIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
POTASSIUM NITRATERU45X2JN0ZACTIB
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-04-08full-release2026-06-01 00:18:19

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
Trader JoesSODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5%TRADER JOE'S COMPANY159abeba-6da2-2643-e063-6394a90a730d2025-10-08WarningsExact identifier
ndc (package): 71270-110-06
ndc (product): 71270-110
ndc11 (package): 71270011006
spl id: 40a9b739-8eb9-6d2f-e063-6294a90a2ba0
spl set id: 159abeba-6da2-2643-e063-6394a90a730d

Reported adverse events (FAERS/openFDA)#

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