SprinJene

Manufacturer
Health and Natural Beauty USA Corp
Effective date
2026-08-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-20 01:01:20

Label at a glance#

ProductSprinJene Natural Sensitivity Relief
Active ingredientSodium Monofluorophosphate, Potassium Nitrate
Label structure9 sections

Dosage and administration

Supervise children as necessary until capable of using without supervision. Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Sodium Monofluorophosphate: 0.76% (0.14% w/v fluoride ion)Anticavity
Potassium Nitrate: 5%Antihypersensitivity

Use

INDICATIONS & USAGE SECTION

Helps remove surface stains with regular brushing, and helps prevent plaque buildup.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Supervise children as necessary until capable of using without supervision. Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Xylitol, Aqua, Glycerin, Precipitated Natural Calcium Carbonate, Hydrated Silica, Zemea (1,3-Propanediol made from Corn), Potassium Cocoate (made from Coconut Oil), Flavor, Zinc Citrate, Xanthan Gum, Acacia Gum, Zinc Oxide, Black Seed Oil (Nigella sativa), Citric Acid, Stevia

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SprinJene®+Sensitivity
Natural
Relief

CAVITY PROTECTION

TOOTHPASTE

with Black Seed Oil (Nigella sativa) & Zinc
Helps Relieve Teeth Sensitivity | Remineralizes Enamel
Helps Dry Mouth | Cleans Teeth | Freshens Breath

NET WT 3.5 OZ (99 g)
Made in USA

To accommodate
the needs of
various lifestyles.

CERTIFIED VEGAN
V
VEGAN.ORG
Vegan

GLUTEN-FREE
ICS
CERTIFIED
Gluten
Free

U
Kosher

HALAL
Halal

Certified

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton
PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63404-1942-12020-01-31C16284748780-19d75b9d0-b8a2-f424-e053-dadaa90a57ceSprinJene ® Natural Sensitivity Relief
63404-1942-12020-01-31C16284748780-19d75b9d0-b8a2-f424-e053-dadaa90a57ceSprinJene ® Natural Sensitivity Relief

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63404-194263404-1942-1

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12017-09-05full-release2026-05-31 22:52:27

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
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact identifier
ndc (package): 63404-1942-1
ndc (product): 63404-1942
ndc11 (package): 63404194201
spl id: 8b20c8a1-ffe1-4f07-b783-b206720640c2
spl set id: 32cc5bc2-60c9-4cb4-acde-485ae494aba2

Reported adverse events (FAERS/openFDA)#

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