SPRINJENE  NATURAL TOTAL CARE CAVITY PROTECTION- sodium fluoride paste, dentifrice 
Health and Natural Beauty USA Corp

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SprinJene
Natural® Total Care Cavity Protection

DRUG FACTS

ACTIVE INGREDIENT

SODIUM FLUORIDE 0.243% (0.14 W/V FLUORIDE ION

PURPOSE

ANTICAVITY

USE

HELPS IN THE PREVENTION OF CAVITIES. HELPS REMOVE SURFACE STAINS WITH REGULAR BRUSHING, AND HELPS PREVENT PLAQUE BUILDUP

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. INSTRUCT CHILDREN 2 TO 6 YEARS 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 (AQUA), HYDRATED SILICA, XYLITOL, GLYCERIN, 1,3 - PROPANEDIOL (ZEMEA - MADE FROM NON-GMO CORN), NATURAL PEPPERMINT OIL, ZINC CITRATE, XANTHAN GUM, SODIUM LAURYL SULFOACETATE (LAL), NIGELLA SATIVA (BLACK SEED OIL), ZINC OXIDE, STEVIA REBAUDIANA EXTRACT, TIO2, ACACIA GUM, PUNICA GRANATUM SEED OIL (POMEGRANATE), THYMUS VULGARIS OIL (THYME), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

MANUFACTURED AND DIST BY : HEALTH AND NATURAL
BEAUTY USA CORP PISCATAWAY, NJ 08854

PRINCIPAL DISPLAY PANEL - 142 GM Tube Carton

SprinJene
Natural®

TOTAL CARE
CAVITY PROTECTION
TOOTHPASTE

BURSTING WITH THE UNIQUE BENEFITS OF
BLACK SEED OIL AND ZINC

NET WT 5OZ (142GM)

USDA
CERTIFIED
BIOBASED
PRODUCT
PRODUCT 100%

CERTIFIED VEGAN
VEGAN.ORG

GLUTEN-FREE
CERTIFIED

PRINCIPAL DISPLAY PANEL - 142 GM Tube Carton
SPRINJENE   NATURAL TOTAL CARE CAVITY PROTECTION
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-6319
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)  
Xylitol (UNII: VCQ006KQ1E)  
PROPANEDIOL (UNII: 5965N8W85T)  
Xanthan Gum (UNII: TTV12P4NEE)  
Zinc Citrate (UNII: K72I3DEX9B)  
Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
ACACIA (UNII: 5C5403N26O)  
ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98)  
SALVIA ROSMARINUS FLOWERING TOP (UNII: 8JM482TI79)  
THYME OIL (UNII: 2UK410MY6B)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63404-6319-11 in 1 CARTON03/01/2024
1142 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02103/01/2024
Labeler - Health and Natural Beauty USA Corp (079129688)
Establishment
NameAddressID/FEIBusiness Operations
Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-6319)

Revised: 5/2024
Document Id: 9c331acb-435c-4e81-b9bd-8ac84a5ca299
Set id: e98a7020-7864-433c-be1f-0640af277ef1
Version: 1
Effective Time: 20240507
 
Health and Natural Beauty USA Corp