SprinJene

Manufacturer
Health and Natural Beauty USA Corp
Effective date
2024-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:22

Label at a glance#

ProductSprinJene Natural Total Care Cavity Protection
Active ingredientSODIUM FLUORIDE
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. INSTRUCT CHILDREN 2 TO 6 YEARS 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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.243% (0.14 W/V FLUORIDE ION

PURPOSE

OTC - PURPOSE SECTION

ANTICAVITY

USE

INDICATIONS & USAGE SECTION

HELPS IN THE PREVENTION OF CAVITIES. 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. INSTRUCT CHILDREN 2 TO 6 YEARS 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

WATER (AQUA), HYDRATED SILICA, XYLITOL, GLYCERIN, 1,3 - PROPANEDIOL (ZEMEA - MADE FROM NON-GMO CORN), NATURAL PEPPERMINT OIL, ZINC CITRATE, XANTHAN GUM, SODIUM LAURYL SULFOACETATE (LAL), NIGELLA SATIVA (BLACK SEED OIL), ZINC OXIDE, STEVIA REBAUDIANA EXTRACT, TIO2, ACACIA GUM, PUNICA GRANATUM SEED OIL (POMEGRANATE), THYMUS VULGARIS OIL (THYME), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

SPL UNCLASSIFIED SECTION

MANUFACTURED AND DIST BY : HEALTH AND NATURAL
BEAUTY USA CORP PISCATAWAY, NJ 08854

PRINCIPAL DISPLAY PANEL - 142 GM Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SprinJene
Natural®

TOTAL CARE
CAVITY PROTECTION
TOOTHPASTE

BURSTING WITH THE UNIQUE BENEFITS OF
BLACK SEED OIL AND ZINC

NET WT 5OZ (142GM)

  • WHITENING
  • REMINERALIZES ENAMEL
  • FRESHENS BREATH
  • HELPS DRY MOUTH
  • SLS FREE
  • PRESERVATIVE FREE
  • DYE FREE
  • NATURAL PEPPERMINT OIL

USDA
CERTIFIED
BIOBASED
PRODUCT
PRODUCT 100%

CERTIFIED VEGAN
VEGAN.ORG

GLUTEN-FREE
CERTIFIED

PRINCIPAL DISPLAY PANEL - 142 GM Tube Carton
PRINCIPAL DISPLAY PANEL - 142 GM Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63404-6319-1SprinJene Natural Total Care Cavity Protection142 g in 1 TUBEPASTE, DENTIFRICE1421
63404-6319-1SprinJene Natural Total Care Cavity Protection1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63404-6319SPRINJENE NATURAL TOTAL CARE CAVITY PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]12 package rows20240511_e98a7020-7864-433c-be1f-0640af277ef1.zip

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
63404-631963404-6319-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
9c331acb-435c-4e81-b9bd-8ac84a5ca299e98a7020-7864-433c-be1f-0640af277ef12024-05-07WarningsExact identifier
spl id: 9c331acb-435c-4e81-b9bd-8ac84a5ca299
spl set id: e98a7020-7864-433c-be1f-0640af277ef1

Reported adverse events (FAERS/openFDA)#

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