SENSITIVE FLUORIDE-FREE - WINTERMINT- 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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Tom's
OF MAINE

Drug Facts

Active ingredients

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

sorbitol, water, hydrated silicas, xylitol, glycerin, organic Aloe barbadensis leaf juice, natural flavors, sodium lauryl sulfate, cocamidopropyl betaine, xanthan gum, titanium dioxide.

Questions?

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

SINCE 1970
Tom's
OF MAINE

fluoride-free
natural

SENSITIVE

clinically proven ingredient to reduce painful sensitivity
toothpaste for sensitive teeth

wintermint

NET WT 4.0 OZ (113 g)

Principal Display Panel - 113 g Tube Carton
SENSITIVE  FLUORIDE-FREE - WINTERMINT
potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-197
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
sorbitol (UNII: 506T60A25R)  
hydrated silica (UNII: Y6O7T4G8P9)  
xylitol (UNII: VCQ006KQ1E)  
glycerin (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
cocamidopropyl betaine (UNII: 5OCF3O11KX)  
sodium lauryl sulfate (UNII: 368GB5141J)  
xanthan gum (UNII: TTV12P4NEE)  
peppermint oil (UNII: AV092KU4JH)  
titanium dioxide (UNII: 15FIX9V2JP)  
spearmint oil (UNII: C3M81465G5)  
menthol, unspecified form (UNII: L7T10EIP3A)  
glycyrrhizin (UNII: 6FO62043WK)  
star anise oil (UNII: 6RXP35EIRE)  
methyl salicylate (UNII: LAV5U5022Y)  
aloe vera leaf (UNII: ZY81Z83H0X)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorWINTERGREEN (Wintermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-197-041 in 1 CARTON09/01/2009
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 finalpart35609/01/2009
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-197)

Revised: 9/2019
Document Id: 88025f94-dded-4b7e-b60e-a05d15fea617
Set id: c31d2178-11c3-4523-a7e1-01aef975d875
Version: 3
Effective Time: 20190912
 
Tom's of Maine, Inc.