FDA.reportPublic FDA data

Sensitivity Relief Fluoride Free Toothpaste

Manufacturer
Health and Natural Beauty USA Corp
Effective date
2026-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-04 05:10:08

Label at a glance#

ProductSensitivity Relief Fluoride Free
Active ingredientPotassium Nitrate
Label structure10 sections

Indications and uses

Helps reduce painful sensitivity of the teeth to cold, heat, acids, and sweets, or contact.

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) 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5%

Purpose

OTC - PURPOSE SECTION

Antihypersensitivity

Uses

INDICATIONS & USAGE SECTION

Helps reduce painful sensitivity of the teeth to cold, heat, acids, and sweets, or contact.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - ASK DOCTOR SECTION

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

OTC - DO NOT USE SECTION

Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

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) 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Xylitol, Hydrated Silica, Calcium Carbonate, Zemea from Non-GMO Corn (1,3-Propanediol), Natural Peppermint Oil, Xanthan Gum, Cocamidopropyl Hydroxysultaine, Zinc Citrate, Zinc Oxide, Black Seed Oil (Nigella Sativa), Stevia Rebaudiana Extract, Sodium Lauryl Sulfoacetate (LAL), Acacia Gum

SPL UNCLASSIFIED SECTION

Manufactured & Dist. by Health and Natural Beauty USA Corp.
Piscataway, NJ 08854

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SprinJene®+Sensitivity
Natural Relief

FLUORIDE FREE

TOOTHPASTE

with BLACK SEED OIL (Nigella sativa) & Zinc

HELPS RELIEVE TEETH SENSITIVITY | FRESHENS BREATH
HELPS DRY MOUTH | CLEANS TEETH

NET WT 3.5 OZ (100 g)
Made in USA

To accommodate
the needs of
various lifestyles.

USDA
CERTIFIED
BIOBASED
PRODUCT
PRODUCT 100%
USDA BIOPREFERRED

CERTIFIED VEGAN
VEGAN.ORG
VEGAN

GLUTEN-FREE
ICS
CERTIFIED
GLUTEN FREE

KOSHER

CRUELTY FREE

Certified

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton
PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63404-210563404-2105-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Potassium NitrateRU45X2JN0ZACTIB
Water059QF0KO0RIACT
glycerinPDC6A3C0OXIACT
XylitolVCQ006KQ1EIACT
Hydrated SilicaY6O7T4G8P9IACT
Calcium carbonateH0G9379FGKIACT
PROPANEDIOL5965N8W85TIACT
Xanthan GumTTV12P4NEEIACT
Zinc citrateK72I3DEX9BIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
Zinc OxideSOI2LOH54ZIACT
Sodium Lauryl sulfoacetateD0Y70F2B9JIACT
Acacia5C5403N26OIACT

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
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
ndc (package): 63404-2105-1
ndc (product): 63404-2105
ndc11 (package): 63404210501
spl id: 8b7a44b8-4906-41dd-a8ec-a56eb779c899
spl set id: c23b2a83-ebc3-4bcf-a216-7693944dcfa0

Reported adverse events (FAERS/openFDA)#

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