SENSITIVE FLUORIDE-FREE - WINTERMINT- potassium nitrate paste, dentifrice

Sensitive by

Drug Labeling and Warnings

Sensitive 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 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

• 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

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)

INGREDIENTS AND APPEARANCE

SENSITIVE  FLUORIDE-FREE - WINTERMINT
potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-197
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
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
Color	WHITE	Score
Shape		Size
Flavor	WINTERGREEN (Wintermint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-197-04	1 in 1 CARTON	09/01/2009
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	09/01/2009

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-197)