SPRINJENE  NATURAL BUBBLE GUM- sodium fluoride paste, dentifrice 
Health and Natural Beauty USA Corp

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SprinJene
Natural® Bubble Gum

Drug Facts

Active Ingredient

Sodium Fluoride 0.243 % (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

Water (Deionized), Xylitol, Sorbitol, Hydrated Silica, Glycerin, Corn Zemea (1,3-Propanediol), Xanthan, Zinc Citrate, Sodium Lauryl Sulfoacetate, Flavor, Acacia Gum, Mica, potassium sorbate, Nigella Sativa Extract (Black seed Oil), Thyme (Thymus Vulgaris), Zingiber officinale (Ginger Oil), Punica granatum Seed Oil (Pomegranate), Commiphora myrrha (Myhrr oil), Rosemary (Rosmarinus Officinalis)

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 - 100 g Tube Carton

SprinJene
Natural®

CAVITY PROTECTION

CHILDREN'S
TOOTHPASTE

with Black Seed Oil & Zinc

BUBBLE GUM

CAVITY
PROTECTION

FRESHENS
BREATH

HELPS
DRY MOUTH

NET WT 3.4 OZ (100g)

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton
SPRINJENE   NATURAL BUBBLE GUM
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-0229
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)  
Xylitol (UNII: VCQ006KQ1E)  
Sorbitol (UNII: 506T60A25R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Glycerin (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
Xanthan Gum (UNII: TTV12P4NEE)  
Zinc Citrate (UNII: K72I3DEX9B)  
Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J)  
ACACIA (UNII: 5C5403N26O)  
Mica (UNII: V8A1AW0880)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
Thyme (UNII: CW657OBU4N)  
GINGER OIL (UNII: SAS9Z1SVUK)  
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
MYRRH OIL (UNII: H74221J5J4)  
ROSEMARY (UNII: IJ67X351P9)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (BUBBLE GUM) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63404-0229-11 in 1 CARTON04/01/2024
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02104/01/2024
Labeler - Health and Natural Beauty USA Corp (079129688)
Establishment
NameAddressID/FEIBusiness Operations
Health and Natural Beuaty USA Corp079129688MANUFACTURE(63404-0229)

Revised: 5/2024
Document Id: 130614b3-4bae-4d9a-9090-9ae1710c9ec5
Set id: 910beaac-1d27-4bdc-8ba3-a270281e676a
Version: 1
Effective Time: 20240507
 
Health and Natural Beauty USA Corp