SPRINJENE  WHITE BOOST- sodium fluoride 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™
White Boost

Drug Facts

Active Ingredient

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Helps in the prevention of caries

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 under 2 to 6 years instruct in good brushing and rinsing habbits (to minimize swallowing).

Children under 2 years do not use unless directed by a dentist or physician.

Inactive Ingredients

Water, hydrated silica, glycerin, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, zinc oxide, tetrasodium pyrophosphate, black seed oil, zinc citrate, titanium dioxide, xanthan gum, sodium saccharin

Questions or comments?

Call toll free 1-844-3-462872
www.sprinjene.com

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

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

NEW

SprinJene™
Fluoride Toothpaste

NET WT 5.0 OZ (142 g)

Bursting with the
unique benefits of
Black Seed Oil

CERTIFIED VEGAN
VEGAN.ORG

White Boost Paste

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton
SPRINJENE   WHITE BOOST
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-1116
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Zinc Oxide (UNII: SOI2LOH54Z)  
Guizotia Abyssinica Seed Oil (UNII: QX0GL46299)  
Sodium Pyrophosphate (UNII: O352864B8Z)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Zinc Citrate (UNII: K72I3DEX9B)  
Xanthan Gum (UNII: TTV12P4NEE)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Mint/Clove) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63404-1116-11 in 1 CARTON
1142 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:63404-1116-21 in 1 CARTON
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 FINALpart35510/10/2014
Labeler - Health and Natural Beauty USA Corp (079129688)
Establishment
NameAddressID/FEIBusiness Operations
Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-1116)

Revised: 2/2015
Document Id: 41ec84a0-b2d2-49c4-9e76-167f20ab9481
Set id: 8c401bea-0148-46a0-bbb3-80c17f9e8e3e
Version: 3
Effective Time: 20150209
 
Health and Natural Beauty USA Corp