SprinJene™

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: 2026-08-20 01:01:49

Label at a glance#

ProductSprinJene White Boost

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 under 2 to 6 years instruct in good brushing and rinsing habbits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician.

Contacts and useful links#

Websitewww.sprinjene.com

www.sprinjene.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Helps in the prevention of caries

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 habbits (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, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, zinc oxide, tetrasodium pyrophosphate, black seed oil, zinc citrate, titanium dioxide, xanthan gum, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-3-462872
www.sprinjene.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 75 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SprinJene^®
Fluoride Toothpaste

NET WT 2.6 OZ (75 g)

Bursting with the unique benefits of
Black Seed Oil

VEGAN
V
BeVeg!

BeVeg
CERTIFIED

ADA
Accepted
American
Dental
Association
®

White Boost
Paste

Principal Display Panel - 75 g Tube Carton

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0363404000916	GTIN-13: 0363404000916 EAN-13: 0363404000916 GTIN-12: 363404000916 UPC-A: 363404000916 GTIN storage (14 digits): 00363404000916	sprinjene-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63404-1116-1	2020-01-31	C162847	48780-1	9d75b9d0-865f-f424-e053-dadaa90a57ce	SprinJene™ White Boost
63404-1116-1	2020-01-31	C162847	48780-1	9d75b9d0-865f-f424-e053-dadaa90a57ce	SprinJene™ White Boost
63404-1116-2	2020-01-31	C162847	48780-1	9d75b9d0-865f-f424-e053-dadaa90a57ce	SprinJene™ White Boost
63404-1116-2	2020-01-31	C162847	48780-1	9d75b9d0-865f-f424-e053-dadaa90a57ce	SprinJene™ White Boost

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	3
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	3
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	3
Guizotia Abyssinica Seed Oil	INACTIVE INGREDIENT	QX0GL46299	3
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	3
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	3
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	3
Sodium Pyrophosphate	INACTIVE INGREDIENT	O352864B8Z	3
Sorbitol	INACTIVE INGREDIENT	506T60A25R	3
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	3
Water	INACTIVE INGREDIENT	059QF0KO0R	3
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	3
Zinc Citrate	INACTIVE INGREDIENT	K72I3DEX9B	3
Zinc Oxide	INACTIVE INGREDIENT	SOI2LOH54Z	3

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

SprinJene White Boost
Sodium Fluoride
Fluoride Ion
Water
Hydrated Silica
Glycerin
Sorbitol
Sodium Lauryl Sulfate
Carboxymethylcellulose Sodium
Zinc Oxide
Guizotia Abyssinica Seed Oil
Sodium Pyrophosphate
Titanium Dioxide
Zinc Citrate
Xanthan Gum
Saccharin Sodium

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63404-1116	63404-1116-1, 63404-1116-2, 63404-1116-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Fluoride	8ZYQ1474W7	ACTIM
Water	059QF0KO0R	IACT
Hydrated Silica	Y6O7T4G8P9	IACT
Glycerin	PDC6A3C0OX	IACT
Sorbitol	506T60A25R	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Carboxymethylcellulose Sodium	K679OBS311	IACT
Zinc Oxide	SOI2LOH54Z	IACT
Guizotia Abyssinica Seed Oil	QX0GL46299	IACT
Sodium Pyrophosphate	O352864B8Z	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Zinc Citrate	K72I3DEX9B	IACT
Xanthan Gum	TTV12P4NEE	IACT
Saccharin Sodium	SB8ZUX40TY	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2015-02-09	full-release	2026-05-31 22:41:42

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 168 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 116 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	SOLUTION / INTRAVENOUS	3.11 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	INJECTION, SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 116 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	SOLUTION / RESPIRATORY (INHALATION)	3.11 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 116 equally ranked IID candidates
Sodium Pyrophosphate	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	SOLUTION / INTRAVENOUS	3.11 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Pyrophosphate	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	INJECTION, SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	INJECTION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	SUPPOSITORY / RECTAL	375 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	INJECTION, SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Zinc Oxide	ZINC OXIDE	SOI2LOH54Z	SUPPOSITORY / RECTAL	375 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 116 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 116 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SprinJene White Boost	SODIUM FLUORIDE	Health and Natural Beauty USA Corp	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	2026-08-14	Warnings	Exact identifier ndc (package): 63404-1116-1 ndc (package): 63404-1116-2 ndc (package): 63404-1116-3 ndc (product): 63404-1116 ndc11 (package): 63404111603 ndc11 (package): 63404111601 ndc11 (package): 63404111602 spl id: b7ffb349-2a06-4ff7-b8bc-0c9975b47c83 spl set id: 8c401bea-0148-46a0-bbb3-80c17f9e8e3e

Reported adverse events (FAERS/openFDA)#

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