FDA.reportPublic FDA data

Jason Total Protection Sensitive

Manufacturer
The Hain Celestial Group, Inc | The Hain Celestial Group, Inc.
Effective date
2021-04-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:37

Label at a glance#

ProductJason Total Protection Sensitive
Active ingredientPOTASSIUM NITRATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5%

OTC - PURPOSE SECTION

Tooth desensitizer

WARNINGS SECTION

Sensitive teeth may indicate a seriuos problem that may need prompt care by a dentist. See your dentist if the problem persists or warsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance immediately.

INDICATIONS & USAGE SECTION

Tooth desensitizer

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Glycerin, Water (Aqua), Xylitol, Hydrated Silica, Sodium Cocoyl Glutamate, Flavor, Eugenia Caryophyllus (Clove) Flower Oil, Mentha Piperita (Peppermint) Oil, Curcuma Longa (Turmeric) Root Extract (1), Etlingera Elatior Flower Extract, Cellulose Gum, Sodium Bicarbonate, Sodium Magnesium Silicate, Sodium Sulfate.

(1) Certified Organic Ingredient

DOSAGE & ADMINISTRATION SECTION

Potassium Nitrate 5%.

Directions: Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP JPGPDP JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312544potassium nitrate 5 % ToothpastePSN3
312544potassium nitrate 0.05 MG/MG ToothpasteSCD3
312544K+ nitrate 0.05 MG/MG ToothpasteSY3
312544Pot nitrate 0.05 MG/MG ToothpasteSY3
312544potassium nitrate 5 % ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-1562-42023-01-30C16284748780-1ba0f9c33-1da5-a910-e053-dadaa90a0b85Jason Total Protection Sensitive Toothpaste
61995-1562-42021-02-05C16284748780-1ba0f9c33-1da5-a910-e053-dadaa90a0b85Jason Total Protection Sensitive Toothpaste
61995-1562-42021-01-29C16284748780-1ba0f9c33-1da5-a910-e053-dadaa90a0b85Jason Total Protection Sensitive Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-1562-4Jason Total Protection Sensitive113 g in 1 TUBEPASTE, DENTIFRICE1133
61995-1562-4Jason Total Protection Sensitive1 in 1 BOXPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-1562JASON TOTAL PROTECTION SENSITIVE (POTASSIUM NITRATE) PASTE, DENTIFRICE [THE HAIN CELESTIAL GROUP, INC]3Legacy NDC, 2 package rows20210413_8e96cb8f-d882-6a17-e053-2a95a90ada5b.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
61995-156261995-1562-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
HYDRATED SILICAY6O7T4G8P9IACT
PEPPERMINT OILAV092KU4JHIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
CURCUMA LONGA WHOLEW5488JUO8UIACT
XYLITOLVCQ006KQ1EIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
SODIUM SULFATE0YPR65R21JIACT
ETLINGERA ELATIOR WHOLEKF7S33DH97IACT
CLOVE OIL578389D6D0IACT

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
bfc91e9b-389e-7977-e053-2a95a90aca518e96cb8f-d882-6a17-e053-2a95a90ada5b2021-04-12WarningsExact identifier
spl id: bfc91e9b-389e-7977-e053-2a95a90aca51
spl set id: 8e96cb8f-d882-6a17-e053-2a95a90ada5b

Reported adverse events (FAERS/openFDA)#

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