SPRINJENE NATURAL  SENSITIVITY AND GUM- potassium nitrate 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 Natural®
Sensitivity & Gum

DRUG FACTS

ACTIVE INGREDIENT

POTASSIUM NITRATE 5%

PURPOSE

ANTIHYPERSENSITIVITY

USE

HELPS REDUCE TOOTH AND GUM SENSITIVITY, 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®

SENSITIVITY & GUM

FLUORIDE FREE

TOOTHPASTE

BURSTING WITH THE UNIQUE BENEFITS OF
BLACK SEED OIL AND ZINC

USDA
CERTIFIED
BIOBASED
PRODUCT
PRODUCT 100%

CERTIFIED VEGAN
VEGAN.ORG

GLUTEN-FREE
CERTIFIED

NET WT 5OZ (142GM)

PRINCIPAL DISPLAY PANEL - 142 GM Tube Carton
SPRINJENE NATURAL   SENSITIVITY AND GUM
potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-1984
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Potassium Nitrate (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) Potassium Nitrate50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
Glycerin (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
Zinc Citrate (UNII: K72I3DEX9B)  
Xanthan Gum (UNII: TTV12P4NEE)  
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
Zinc Oxide (UNII: SOI2LOH54Z)  
STEVIA SERRATA FLOWER OIL (UNII: 93Z447IP63)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Acacia (UNII: 5C5403N26O)  
POMEGRANATE (UNII: 56687D1Z4D)  
THYME OIL (UNII: 2UK410MY6B)  
TEA TREE OIL (UNII: VIF565UC2G)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINT (Minty) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63404-1984-11 in 1 CARTON02/20/2021
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 NOT FINALpart35602/20/2021
Labeler - Health and Natural Beauty USA Corp (079129688)
Establishment
NameAddressID/FEIBusiness Operations
Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-1984)

Revised: 1/2021
Document Id: b01c14e4-8033-4644-ad5a-5d85c5e24a5b
Set id: 3cb23e36-0e8c-4172-b4ae-859b58a2739f
Version: 1
Effective Time: 20210112
 
Health and Natural Beauty USA Corp