SPRINJENE NATURAL  SENSITIVITY RELIEF- sodium monofluorophosphate and potassium nitrate paste, dentifrice 
Health and Natural Beauty USA Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

SprinJene® Natural
Sensitivity Relief

Drug Facts

Active IngredientPurpose
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

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

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton
SPRINJENE NATURAL   SENSITIVITY RELIEF
sodium monofluorophosphate and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-1942
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.5 mg  in 1 g
Potassium Nitrate (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) Potassium Nitrate50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63404-1942-11 in 1 CARTON07/01/2017
199 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/2017
Labeler - Health and Natural Beauty USA Corp (079129688)
Establishment
NameAddressID/FEIBusiness Operations
Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-1942)

Revised: 9/2017
Document Id: c00995ff-76f6-4ec9-ad97-a9c4e911e284
Set id: 32cc5bc2-60c9-4cb4-acde-485ae494aba2
Version: 1
Effective Time: 20170905
 
Health and Natural Beauty USA Corp