SprinJene ® SprinJene ® Health Boost Gel

Manufacturer
Health and Natural Beauty USA Corp
Effective date
2026-08-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-08-21 02:01:50

Label at a glance#

ProductSprinJene Health Boost
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 2-6 years old 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% (0.15% 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 2-6 years old 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

Aqua, Hydrated Silica, Sorbitol, Xylitol, Glycerin, Poloxamer 407, Cocamidopropyl Hydroxysultaine, Flavor (Peppermint and Clove), Cellulose Gum, Zinc Citrate, Zinc Oxide, Sodium Lauryl Sulfoacetate (LAL), Nigella Sativa (Black Seed Oil), Xanthan Gum, Stevia Rebaudiana Extract

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-346-2872

www.sprinjene.com

SPL UNCLASSIFIED SECTION

Manufactured & Dist. by:

Health and Natural Beauty USA Corp,
Piscataway, NJ 08854

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SprinJene®
Fluoride Toothpaste

Bursting with the
unique benefits of
Black Seed Oil

VEGAN
V
BeVeg!
BEVEG
CERTIFIED

NET WT 5.0 OZ (142 g)

Health Boost Paste

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

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63404-110863404-1108-1, 63404-1108-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32023-02-02full-release2026-05-31 23:54:12

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 Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
ndc (package): 63404-1108-1
ndc (package): 63404-1108-2
ndc (product): 63404-1108
ndc11 (package): 63404110802
ndc11 (package): 63404110801
spl id: 2c7c212f-b7da-47a0-bbfb-73fd530e252a
spl set id: 9be87bcd-403a-4d7e-8ded-9833249565d1

Reported adverse events (FAERS/openFDA)#

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