SPRINJENE NATURAL BUBBLE GUM- sodium fluoride paste, dentifrice

SprinJene by

Drug Labeling and Warnings

SprinJene by is a Otc medication manufactured, distributed, or labeled by Health and Natural Beauty USA Corp, Health and Natural Beuaty USA Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sodium Fluoride 0.243 % (0.14 W/V Fluoride Ion)

Purpose

Anticavity

Use

Helps in the prevention of cavities.

Warnings

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

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

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)

Questions or comments?

Call 1-844-346-2872

www.sprinjene.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

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)

INGREDIENTS AND APPEARANCE

SPRINJENE   NATURAL BUBBLE GUM
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63404-0229
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
Xanthan Gum (UNII: TTV12P4NEE)
Zinc Citrate (UNII: K72I3DEX9B)
Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J)
ACACIA (UNII: 5C5403N26O)
Mica (UNII: V8A1AW0880)
Potassium Sorbate (UNII: 1VPU26JZZ4)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
Thyme (UNII: CW657OBU4N)
GINGER OIL (UNII: SAS9Z1SVUK)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
MYRRH OIL (UNII: H74221J5J4)
ROSEMARY (UNII: IJ67X351P9)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM (BUBBLE GUM)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63404-0229-1	1 in 1 CARTON	04/01/2024
1		100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M021	04/01/2024

Labeler - Health and Natural Beauty USA Corp (079129688)

Establishment
Name	Address	ID/FEI	Business Operations
Health and Natural Beuaty USA Corp		079129688	MANUFACTURE(63404-0229)