MAXIMUM STRENGTH SENSITIVE

Drug Labeling and Warnings

Drug Details [pdf]

MAXIMUM STRENGTH SENSITIVE SOOTHING MINT- sodium fluoride and 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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MAXIMUM STRENGTH
SENSITIVE

Drug Facts

• 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, Gaultheria procumbens (wintergreen) leaf oil and other natural flavors, cocamidopropyl betaine, sodium lauryl sulfate, 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 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

soothing mint

NET WT 4.0 OZ (113 g)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-166
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)
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
Aloe Vera leaf (UNII: ZY81Z83H0X)
methyl salicylate (UNII: LAV5U5022Y)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
sodium lauryl sulfate (UNII: 368GB5141J)
xanthan gum (UNII: TTV12P4NEE)
titanium dioxide (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-166-04	1 in 1 BOX	09/01/2009	02/01/2015
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	09/01/2009	02/01/2015

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

Revised: 9/2019

Document Id: 79f90463-0709-4b93-af1a-6c9c094fa110

34390-5

Set id: 1b45c897-482c-4133-9a93-ee20e16e30e6

Version: 3

Effective Time: 20190907