MAXIMUM STRENGTH SENSITIVE TRUE MINT- sodium fluoride and potassium nitrate paste, dentifrice

Maximum Strength Sensitive by

Drug Labeling and Warnings

Maximum Strength 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]

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Drug Facts

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Potassium nitrate 5%: Tooth desensitizer
• Sodium fluoride 0.24% (0.15 w/v fluoride ion): Anticavity

Uses

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

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, hydrated silica, xylitol, water, glycerin, organic Aloe barbadensis leaf juice, Mentha piperita (peppermint) oil and other natural flavors, 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

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© 2010 Tom's of Maine, Inc.
302 Lafayette Ctr.
Kennebunk, ME 04043

PRINCIPAL DISPLAY PANEL - 113 g Box

SINCE 1970
Tom's
OF MAINE™

maximum strength* | natural

SENSITIVE

clinically proven to reduce painful sensitivity

toothpaste for sensitive teeth
and cavity prevention with fluoride

true mint

NET WT 4.0 OZ (113 g)

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH SENSITIVE  TRUE MINT
sodium fluoride and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-167
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	0.00243 g  in 1 g
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)
aloe vera leaf (UNII: ZY81Z83H0X)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
xanthan gum (UNII: TTV12P4NEE)
peppermint oil (UNII: AV092KU4JH)
titanium dioxide (UNII: 15FIX9V2JP)
spearmint oil (UNII: C3M81465G5)
menthol, unspecified form (UNII: L7T10EIP3A)
glycyrrhizin (UNII: 6FO62043WK)
Anise (UNII: 21C2F5E8RE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	SPEARMINT (True Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-167-04	1 in 1 BOX	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(51009-167)