SPRINJENE  NATURAL- sodium monofluorophosphate 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.

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SprinJene®
Natural

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, Sodium Bicarbonate, Zinc Citrate, Guar Gum, Xanthan Gum, Black Seed Oil (Nigella sativa), Zinc Oxide, Stevia Rebaudiana Extract, Pectin.

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®
Natural

with Fluoride

TOOTHPASTE

with BLACK SEED OIL (Nigella sativa) & ZINC

CAVITY PROTECTION | REMINERALIZES ENAMEL | HELPS DRY MOUTH

NET WT 3.5 OZ (99 g)
Made in USA

To accommodate
the needs of
various lifestyles.

Certified:

CERTIFIED VEGAN
VEGAN.ORG
Vegan

GLUTEN-FREE
CERTIFIED
Gluten
Free

U
Kosher

HALAL
Halal

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton
SPRINJENE   NATURAL
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-0201
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
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Xylitol (UNII: VCQ006KQ1E)  
Glycerin (UNII: PDC6A3C0OX)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Calcium Carbonate (UNII: H0G9379FGK)  
Acacia (UNII: 5C5403N26O)  
Propanediol (UNII: 5965N8W85T)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Sodium Bicarbonate (UNII: 8MDF5V39QO)  
Zinc Citrate (UNII: K72I3DEX9B)  
Guar Gum (UNII: E89I1637KE)  
Xanthan Gum (UNII: TTV12P4NEE)  
Zinc Oxide (UNII: SOI2LOH54Z)  
Pectin (UNII: 89NA02M4RX)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Minty) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63404-0201-11 in 1 CARTON02/01/2017
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 FINALpart35502/01/2017
Labeler - Health and Natural Beauty USA Corp (079129688)
Establishment
NameAddressID/FEIBusiness Operations
Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-0201)

Revised: 1/2017
Document Id: e7a26348-1e2a-45bb-98ec-acd036d48cf8
Set id: e64cecc3-0845-4bdf-a449-d78248791ccf
Version: 1
Effective Time: 20170117
 
Health and Natural Beauty USA Corp