SPRINJENE HEALTH BOOST- 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]

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Drug Facts

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.15% 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 w ithout 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

Aqua, hydrated silica, sorbitol, glycerin, xylitol, erythritol, poloxamer 407, cocamidopropyl betaine, flavor, cellulose gum, zinc citrate, zinc oxide, sodium lauryl sulfoacetate, nigella sativa oil (black seed oil), titanium dioxide, xanthan gum

Questions or comments?

Call toll free 1-844-346-2872
www.sprinjene.com

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

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

SprinJene®
Fluoride Toothpaste

NET WT 5 OZ (142g)

Bursting with the
unique benefits of
Black Seed Oil

CERTIFIED VEGAN
VEGAN.ORG

Health Boost Paste

INGREDIENTS AND APPEARANCE

SPRINJENE   HEALTH BOOST
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63404-1108
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)
Hydrated Silica (UNII: Y6O7T4G8P9)
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Xylitol (UNII: VCQ006KQ1E)
Erythritol (UNII: RA96B954X6)
Poloxamer 407 (UNII: TUF2IVW3M2)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Zinc Citrate (UNII: K72I3DEX9B)
Zinc Oxide (UNII: SOI2LOH54Z)
Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J)
Nigella Sativa Seed Oil (UNII: CS4U38E731)
Titanium Dioxide (UNII: 15FIX9V2JP)
Xanthan Gum (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT (Minty)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63404-1108-1	1 in 1 CARTON	07/01/2016
1		142 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 63404-1108-2	1 in 1 CARTON	07/01/2016
2		42 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	07/01/2016

Labeler - Health and Natural Beauty USA Corp (079129688)

Establishment
Name	Address	ID/FEI	Business Operations
Health and Natural Beauty USA Corp		079129688	MANUFACTURE(63404-1108)