Sensitive

Manufacturer: Tom's of Maine, Inc.
Effective date: 2019-09-12
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:12:21

Label at a glance#

ProductSensitive fluoride-free - Wintermint

Active ingredientPotassium Nitrate

Label structure9 sections

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact(412) 390-3381

PhoneLabel contact1-800-FOR-TOMS

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%

Purpose

OTC - PURPOSE SECTION

Tooth desensitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product, do not use longer than 4 weeks unless recommended by a dentist or physician.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51009-197-04	2024-11-25	C162847	48780-1	ba0f9c33-5165-a910-e053-dadaa90a0b85	Tom's ™ OF MAINE
51009-197-04	2021-01-29	C162847	48780-1	ba0f9c33-5165-a910-e053-dadaa90a0b85	Tom's ™ OF MAINE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Potassium Nitrate	ACTIVE INGREDIENT	RU45X2JN0Z	1
Potassium Cation	ACTIVE MOIETY	295O53K152	1
cocamidopropyl betaine	INACTIVE INGREDIENT	5OCF3O11KX	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
glycyrrhizin	INACTIVE INGREDIENT	6FO62043WK	1
hydrated silica	INACTIVE INGREDIENT	Y6O7T4G8P9	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
water	INACTIVE INGREDIENT	059QF0KO0R	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	1
xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

Sensitive fluoride-free - Wintermint
Potassium Nitrate
Nitrate Ion
sorbitol
hydrated silica
xylitol
glycerin
water
cocamidopropyl betaine
sodium lauryl sulfate
xanthan gum
peppermint oil
titanium dioxide
spearmint oil
menthol, unspecified form
glycyrrhizin
star anise oil
methyl salicylate
aloe vera leaf

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51009-197	51009-197-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Potassium Nitrate	RU45X2JN0Z	ACTIB
sorbitol	506T60A25R	IACT
hydrated silica	Y6O7T4G8P9	IACT
xylitol	VCQ006KQ1E	IACT
glycerin	PDC6A3C0OX	IACT
water	059QF0KO0R	IACT
cocamidopropyl betaine	5OCF3O11KX	IACT
sodium lauryl sulfate	368GB5141J	IACT
xanthan gum	TTV12P4NEE	IACT
peppermint oil	AV092KU4JH	IACT
titanium dioxide	15FIX9V2JP	IACT
spearmint oil	C3M81465G5	IACT
menthol, unspecified form	L7T10EIP3A	IACT
glycyrrhizin	6FO62043WK	IACT
star anise oil	6RXP35EIRE	IACT
methyl salicylate	LAV5U5022Y	IACT
aloe vera leaf	ZY81Z83H0X	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 266 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
menthol	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
xylitol	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
xylitol	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	POWDER / VAGINAL	3 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	PASTE, DENTIFRICE / DENTAL	4.7 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d2da6a37-7444-4d55-898f-3dd0c3fc46b1			c31d2178-11c3-4523-a7e1-01aef975d875	2019-09-12	Warnings	Exact identifier spl set id: c31d2178-11c3-4523-a7e1-01aef975d875

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.