FDA.reportPublic FDA data

SprinJene

Manufacturer
Health and Natural Beauty USA Corp | Health and Natural Beuaty USA Corp
Effective date
2024-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:21

Label at a glance#

ProductSprinJene Natural Bubble Gum
Active ingredientSodium Fluoride
Label structure10 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

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.

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

Water (Deionized), Xylitol, Sorbitol, Hydrated Silica, Glycerin, Corn Zemea (1,3-Propanediol), Xanthan, Zinc Citrate, Sodium Lauryl Sulfoacetate, Flavor, Acacia Gum, Mica, potassium sorbate, Nigella Sativa Extract (Black seed Oil), Thyme (Thymus Vulgaris), Zingiber officinale (Ginger Oil), Punica granatum Seed Oil (Pomegranate), Commiphora myrrha (Myhrr oil), Rosemary (Rosmarinus Officinalis)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SprinJene
Natural®

CAVITY PROTECTION

CHILDREN'S
TOOTHPASTE

with Black Seed Oil & Zinc

BUBBLE GUM

CAVITY
PROTECTION

FRESHENS
BREATH

HELPS
DRY MOUTH

NET WT 3.4 OZ (100g)

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton
PRINCIPAL DISPLAY PANEL - 100 g 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
63404-0229-1SprinJene Natural Bubble Gum100 g in 1 TUBEPASTE, DENTIFRICE1001
63404-0229-1SprinJene Natural Bubble Gum1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63404-0229SPRINJENE NATURAL BUBBLE GUM (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]12 package rows20240511_910beaac-1d27-4bdc-8ba3-a270281e676a.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63404-022963404-0229-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
XylitolVCQ006KQ1EIACT
Sorbitol506T60A25RIACT
Hydrated SilicaY6O7T4G8P9IACT
GlycerinPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
Xanthan GumTTV12P4NEEIACT
Zinc CitrateK72I3DEX9BIACT
Sodium Lauryl SulfoacetateD0Y70F2B9JIACT
ACACIA5C5403N26OIACT
MicaV8A1AW0880IACT
Potassium Sorbate1VPU26JZZ4IACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
ThymeCW657OBU4NIACT
GINGER OILSAS9Z1SVUKIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
MYRRH OILH74221J5J4IACT
ROSEMARYIJ67X351P9IACT

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
130614b3-4bae-4d9a-9090-9ae1710c9ec5910beaac-1d27-4bdc-8ba3-a270281e676a2024-05-07WarningsExact identifier
spl id: 130614b3-4bae-4d9a-9090-9ae1710c9ec5
spl set id: 910beaac-1d27-4bdc-8ba3-a270281e676a

Reported adverse events (FAERS/openFDA)#

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