TOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS- potassium nitrate paste, dentifrice

Toms Natural Fluoride-free Strength Sensitive Wintermint by

Drug Labeling and Warnings

Toms Natural Fluoride-free Strength Sensitive Wintermint by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• adults and children 12 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
• children under 12 years of age: consult a dentist or physician

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)

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-214
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	MINT (Wintermint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-214-40	1 in 1 CARTON	05/01/2015
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	05/01/2015

Labeler - Tom's of Maine, Inc. (052764354)

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-214)