SPRINJENE NATURAL APPLE-MINT- sodium monofluorophosphate paste, dentifrice SPRINJENE NATURAL WATERMELON- sodium monofluorophosphate 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sodium Monofluorophosphate: 0.76% (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

Aqua, Xylitol, Glycerin, Silica, Calcium Carbonate, Acacia Gum, Corn Zemea (1,3-Propanediol), Vegetable Betaine (Cocamidopropyl Betaine), Flavor, Black Seed Oil (Nigella sativa), Guar Gum, Xanthan Gum, Sodium Bicarbonate, Stevia Rebaudiana Extract, Zinc Citrate, Pectin.

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 - 99 g Tube Carton - Natural Apple-Mint

with Fluoride
TOOTHPASTE FOR CHILDREN

• ✓ Vegan
• ✓ Gluten Free
• ✓ Preservative Free
• ✓ Dye Free
• ✓ Artificial
  Sweetener Free
• ✓ SLS Free

SprinJene®
Natural

APPLE-MINT
uses
Natural Flavor

with Black Seed Oil (Nigella sativa) & Zinc
Birch Tree Xylitol & Acacia Gum

NET WT 3.5 OZ (99 g)

CERTIFIED VEGAN
VEGAN.ORG
Vegan

GLUTEN-FREE
CERTIFIED
Gluten Free

U
Kosher

HALAL
Halal

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton - Natural Watermelon

with Fluoride
TOOTHPASTE FOR CHILDREN

• ✓ Vegan
• ✓ Gluten Free
• ✓ Preservative Free
• ✓ Dye Free
• ✓ Artificial
  Sweetener Free
• ✓ SLS Free

SprinJene®
Natural

WATERMELON
uses
Natural Flavor

with Black Seed Oil (Nigella sativa) & Zinc
Birch Tree Xylitol & Acacia Gum

NET WT 3.5 OZ (99 g)

CERTIFIED VEGAN
VEGAN.ORG
Vegan

GLUTEN-FREE
CERTIFIED
Gluten Free

U
Kosher

HALAL
Halal

INGREDIENTS AND APPEARANCE

SPRINJENE   NATURAL APPLE-MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63404-2014
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Glycerin (UNII: PDC6A3C0OX)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Calcium Carbonate (UNII: H0G9379FGK)
Acacia (UNII: 5C5403N26O)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Guar Gum (UNII: E89I1637KE)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Bicarbonate (UNII: 8MDF5V39QO)
Zinc Citrate (UNII: K72I3DEX9B)
Pectin (UNII: 89NA02M4RX)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	WATERMELON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63404-2014-1	1 in 1 CARTON	02/01/2017
1		99 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 FINAL	part355	02/01/2017

SPRINJENE   NATURAL WATERMELON
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63404-1203
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Glycerin (UNII: PDC6A3C0OX)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Calcium Carbonate (UNII: H0G9379FGK)
Acacia (UNII: 5C5403N26O)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Guar Gum (UNII: E89I1637KE)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Bicarbonate (UNII: 8MDF5V39QO)
Zinc Citrate (UNII: K72I3DEX9B)
Pectin (UNII: 89NA02M4RX)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	WATERMELON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63404-1203-1	1 in 1 CARTON	02/01/2017
1		99 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 FINAL	part355	02/01/2017

Labeler - Health and Natural Beauty USA Corp (079129688)

Establishment
Name	Address	ID/FEI	Business Operations
Health and Natural Beauty USA Corp		079129688	MANUFACTURE(63404-2014, 63404-1203)