SPRINJENE  HEALTH BOOST- 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®
Health Boost

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

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

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton
SPRINJENE   HEALTH BOOST
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-1108
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)  
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 (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
ColorWHITEScore    
ShapeSize
FlavorMINT (Minty) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63404-1108-11 in 1 CARTON07/01/2016
1142 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:63404-1108-21 in 1 CARTON07/01/2016
242 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/01/2016
Labeler - Health and Natural Beauty USA Corp (079129688)
Establishment
NameAddressID/FEIBusiness Operations
Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-1108)

Revised: 2/2023
Document Id: ffb7f805-b6df-43fa-a817-f1d00780be24
Set id: 9be87bcd-403a-4d7e-8ded-9833249565d1
Version: 3
Effective Time: 20230202
 
Health and Natural Beauty USA Corp