SPRINJENE NATURAL SENSITIVITY RELIEF- sodium monofluorophosphate and potassium nitrate paste, dentifrice

SprinJene Natural by

Drug Labeling and Warnings

SprinJene Natural 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

Active Ingredient	Purpose
Sodium Monofluorophosphate: 0.76% (0.14% w/v fluoride ion)	Anticavity
Potassium Nitrate: 5%	Antihypersensitivity

Use

Helps remove surface stains with regular brushing, and helps prevent plaque buildup.

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

Xylitol, Aqua, Glycerin, Precipitated Natural Calcium Carbonate, Hydrated Silica, Zemea (1,3-Propanediol made from Corn), Potassium Cocoate (made from Coconut Oil), Flavor, Zinc Citrate, Xanthan Gum, Acacia Gum, Zinc Oxide, Black Seed Oil (Nigella sativa), Citric Acid, Stevia

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

SprinJene®+Sensitivity
Natural
Relief

CAVITY PROTECTION

TOOTHPASTE

with Black Seed Oil (Nigella sativa) & Zinc
Helps Relieve Teeth Sensitivity | Remineralizes Enamel
Helps Dry Mouth | Cleans Teeth | Freshens Breath

NET WT 3.5 OZ (99 g)
Made in USA

To accommodate
the needs of
various lifestyles.

CERTIFIED VEGAN
V
VEGAN.ORG
Vegan

GLUTEN-FREE
ICS
CERTIFIED
Gluten
Free

U
Kosher

HALAL
Halal

Certified

INGREDIENTS AND APPEARANCE

SPRINJENE NATURAL   SENSITIVITY RELIEF
sodium monofluorophosphate and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63404-1942
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
Potassium Nitrate (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	Potassium Nitrate	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Calcium Carbonate (UNII: H0G9379FGK)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Propanediol (UNII: 5965N8W85T)
Potassium Cocoate (UNII: F8U72V8ZXP)
Zinc Citrate (UNII: K72I3DEX9B)
Xanthan Gum (UNII: TTV12P4NEE)
Acacia (UNII: 5C5403N26O)
Zinc Oxide (UNII: SOI2LOH54Z)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63404-1942-1	1 in 1 CARTON	07/01/2017
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 not final	part356	07/01/2017

Labeler - Health and Natural Beauty USA Corp (079129688)

Establishment
Name	Address	ID/FEI	Business Operations
Health and Natural Beauty USA Corp		079129688	MANUFACTURE(63404-1942)