Sensitivity & Gum with Cavity Protection

Manufacturer
Health and Natural Beauty USA Corp
Effective date
2026-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:45

Label at a glance#

ProductSensitivity and Gum with Cavity Protection
Active ingredientPotassium Nitrate, Sodium Fluoride
Label structure9 sections

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

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

  • Aids in prevention of cavities.
  • 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. "Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. 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 (Aqua), Glycerin, Hydrated Silica, Xylitol, 1,3 - Propanediol (Zemea - made from non-GMO Corn), Natural Peppermint Oil, Cocamidopropyl Hydroxysultaine (from Coconut Oil), Zinc Citrate, Xanthan Gum, Nigella Sativa (Black Seed Oil), Sodium Hydroxide, TiO2, Stevia Rebaudiana Extract, Acacia Gum, Echinacea Purpurea (Coneflower Extract), Commiphora Myrrha (Myrrh Oil), Rosmarinus Officinalis (Rosemary Oil), Thymus Vulgaris Oil (Thyme ), Eugenia Caryophyllus (Clove Bud Oil), Cocos Nucifera (Coconut Oil), Zingiber Officinale (Ginger Oil), Hydrastis Canadensis (Goldenseal Root), Melaleuca Alternifolia (Tea Tree Oil), Hippophae Rhamnoides (Sea Buckthorn Fruit Oil), Punica Granatum (Pomegranate Seed Oil)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SprinJene
Natural®

SENSITIVITY & GUM

CAVITY PROTECTION

TOOTHPASTE

BURSTING WITH THE
UNIQUE BENEFITS OF
BLACK SEED OIL
AND ZINC

  • POMEGRANATE
  • TEA TREE OIL
  • THYME

FREE FROM:
SLS • DYE • PRESERVATIVES

NATURAL PEPPERMINT OIL

NET WT 5 OZ (142g)

CERTIFIED:

CERTIFIED VEGAN
VEGAN.ORG
VEGAN

GLUTEN-FREE
ICS
CERTIFIED
GLUTEN FREE

USDA
CERTIFIED
BIOBASED
PRODUCT
PRODUCT 100%
USDA BIOPREFERRED

KOSHER

CRUELTY FREE

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton
PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1426152potassium nitrate 5 % / sodium monofluorophosphate 0.76 % ToothpastePSN1
1426152potassium nitrate 0.05 MG/MG / sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
1426152K+ nitrate 0.05 MG/MG / Sodium monofluorophosphate 0.0076 MG/MG ToothpasteSY1
1426152Pot nitrate 0.05 MG/MG / Sodium monofluorophosphate 0.0076 MG/MG ToothpasteSY1
1426152potassium nitrate 5 % / sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % ) ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363404001265GTIN-13: 0363404001265
EAN-13: 0363404001265
GTIN-12: 363404001265
UPC-A: 363404001265
GTIN storage (14 digits): 00363404001265
sprinjene-01.jpg
QR code linkQR Codeqr.ly/3oldsprinjene-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63404-2210-1Sensitivity and Gum with Cavity Protection142 g in 1 TUBEPASTE, DENTIFRICE1421
63404-2210-1Sensitivity and Gum with Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE11

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63404-221063404-2210-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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 and Gum with Cavity ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHealth and Natural Beauty USA Corp137d6935-19a3-499d-957c-820156eec7a52026-05-22WarningsExact identifier
ndc (package): 63404-2210-1
ndc (product): 63404-2210
ndc11 (package): 63404221001
spl id: 8bccdcbd-ce36-40b0-a3e9-6c5d3c004242
spl set id: 137d6935-19a3-499d-957c-820156eec7a5

Reported adverse events (FAERS/openFDA)#

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