SprinJene

Manufacturer
Health and Natural Beauty USA Corp
Effective date
2026-08-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-21 02:02:02

Label at a glance#

ProductSprinJene Natural
Active ingredientSodium Monofluorophosphate
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 under 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 Monofluorophosphate 0.76% (0.14 W/V Fluoride Ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental 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 under 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, Hydrated Silica, Glycerin, Xylitol, 1,3 Propanediol (Zemea - made from non GMO corn), Natural Peppermint Oil, Xanthan Gum, Precipitated Natural Calcium Carbonate, Zinc Citrate, Cocamidopropyl Hydroxysultaine, Zinc Oxide, Nigella Sativa (Black Seed Oil), Stevia Rebaudiana Extract, Sodium Lauryl Sulfoacetate (LAL), Tetrasodium Pyrophosphate, Acacia Gum.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-346-2872 www.sprinjene.com
inquiries@sprinjene.com

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®
Natural

CAVITY PROTECTION
TOOTHPASTE

with BLACK SEED OIL (Nigella Sativa) & ZINC
REMINERALIZES ENAMEL | CLEANS TEETH
FRESHENS BREATH

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

CRUELTY FREE

KOSHER

GF™ CERTIFIED
GLUTEN FREE

Certified

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63404-0201-12020-01-31C16284748780-19d75b9d1-1f23-f424-e053-dadaa90a57ceSprinJene ® Natural
63404-0201-12020-01-31C16284748780-19d75b9d1-1f23-f424-e053-dadaa90a57ceSprinJene ® SprinJene ® Natural Cavity Protection

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
63404-020163404-0201-1

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12017-01-17full-release2026-05-31 22:48:41

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 NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
ndc (package): 63404-0201-1
ndc (product): 63404-0201
ndc11 (package): 63404020101
spl id: d02d031a-f428-4114-b5f3-8a518ffc08cf
spl set id: e64cecc3-0845-4bdf-a449-d78248791ccf

Reported adverse events (FAERS/openFDA)#

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