TOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT  CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS- potassium nitrate paste, dentifrice 
Tom's of Maine, Inc.

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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Toms Natural Fluoride-free Strength Sensitive Wintermint Toothpaste
clinically proven to reduce painful sensitivity / no artificial dyes or sweeteners

Drug Facts

Active ingredient

Potassium nitrate 5%

Purpose

Tooth desensitizer

Use

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Warnings

When using this product, do not use longer than 4 weeks unless recommended by a dentist or physician.

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

Directions

Inactive ingredients

water, sorbitol, hydrated silica, xylitol, glycerin, natural flavor1, sodium lauryl sulfate, cocamidopropyl betaine, xanthan gum, titianium dioxide.


1
wintergreen oil and other natural flavor

Questions?

1-800-FOR-TOMS (1-800-367-8667)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

SINCE 1970
Tom's®
OF MAINE

fluoride-free | natural

SENSITIVE

toothpaste for sensitive teeth
clinically proven to reduce painful sensitivity
no artificial dyes or sweeteners

wintermint

NET WT 4.0 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
TOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT   CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS
potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-214
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Wintermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-214-401 in 1 CARTON05/01/2015
1113 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 FINALpart35605/01/2015
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-214)

Revised: 4/2015
Document Id: be324274-e18f-43f9-b57c-e35a11747518
Set id: 898ed820-07e6-4633-a8cd-73ad9d33cafa
Version: 2
Effective Time: 20150420
 
Tom's of Maine, Inc.