TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT  CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS- potassium nitrate and sodium fluoride 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.

----------

Toms® Natural Maximum Strength Sensitive Soothing Mint Toothpaste
clinically proven to reduce painful sensitivity / no artificial dyes or sweeteners

Drug Facts

Active ingredientsPurpose
Potassium nitrate 5%Tooth desensitizer
Sodium fluoride 0.24% (0.15 w/v fluoride ion)Anticavity

Uses

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, titanium 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

maximum strength* | natural

SENSITIVE

toothpaste for sensitive teeth
and cavity prevention with fluoride

clinically proven to reduce painful sensitivity

no artificial dyes or sweeteners

soothing mint

NET WT 4.0 OZ (113 g)

Principal Display Panel - 113 g Tube Carton
TOMS NATURAL MAXIMUM STRENGTH SENSITIVE SOOTHING MINT   CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS
potassium nitrate and sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-213
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
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.00243 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 (Soothing Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-213-401 in 1 CARTON03/01/2015
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 FINALpart35603/01/2015
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-213)

Revised: 2/2015
Document Id: 7ffb81cb-bec2-40f5-b518-5fece58ad173
Set id: 47eb45ad-a5b1-4ef5-aa07-099afb369a08
Version: 2
Effective Time: 20150227
 
Tom's of Maine, Inc.