SPRINJENE  FRESH BOOST- sodium fluoride gel, 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™
Fresh 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, sorbitol, glycerin, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, zinc citrate, black seed oil, xanthan, sodium saccharin, mica, FD&C Blue No. 1, FD&C Yellow No. 5

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 - 130 g Tube Carton

NEW

SprinJene™
Fluoride Toothpaste

Bursting with the
unique benefits of
Black Seed Oil

CERTIFIED VEGAN
VEGAN.ORG

Fresh Boost Gel

NET WT 4.6 OZ (130 g)

Principal Display Panel - 130 g Tube Carton
SPRINJENE   FRESH BOOST
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-0910
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, UNSPECIFIED (UNII: K679OBS311)  
Zinc Citrate (UNII: K72I3DEX9B)  
Guizotia Abyssinica Seed Oil (UNII: QX0GL46299)  
Sodium Pyrophosphate (UNII: O352864B8Z)  
Xanthan Gum (UNII: TTV12P4NEE)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Mica (UNII: V8A1AW0880)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (Minty) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63404-0910-11 in 1 CARTON10/10/2014
1130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:63404-0910-21 in 1 CARTON10/10/2014
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(63404-0910)

Revised: 2/2023
Document Id: 0c99f36a-9b4e-47e7-a22d-e7245c26eae0
Set id: 919f6f51-6c43-4f1c-9bc7-029bf76c0e68
Version: 3
Effective Time: 20230202
 
Health and Natural Beauty USA Corp