tom's

tom's
SPL v6
SPL
SPL Set ID 204a3eec-3d91-456d-bc15-51363f25e711
Route
dental
Published
Effective Date 2023-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.00243 g)
Inactive Ingredients
sorbitol water hydrated silica glycerin xylitol sodium lauryl sulfate xanthan gum carrageenan titanium dioxide sodium hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2011-08-29 Until 2026-10-01
Purpose

Anticavity

Description

Drug Facts

Medication Information

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients

water, sorbitol, hydrated silica, xylitol, glycerin, sodium lauryl sulfate, natural flavor

peppermint oil and other natural flavor
, xanthan gum, sodium hydroxide, carrageenan, titanium dioxide.

Description

Drug Facts

Questions?

1-800-FOR-TOMS (1-800-367-8667)

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

Active Ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Principal Display Panel 113 G Tube Carton

THE ORIGINAL

Tom's

OF MAINE

ADA

Accepted

American

Dental

Association ®

NATURAL • WITH FLUORIDE

SIMPLY

WHITE®

anticavity toothpaste

CLEAN MINT

4.0 OZ (113 g)

CLINICALLY PROVEN

WHITENING

REMINERALIZES ENAMEL

PREVENTS CAVITIES

NO

ANIMAL TESTING,

ARTIFICIAL FLAVORS,

SWEETENERS OR DYES

Structured Label Content

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, xylitol, glycerin, sodium lauryl sulfate, natural flavor

peppermint oil and other natural flavor
, xanthan gum, sodium hydroxide, carrageenan, titanium dioxide.

Questions?

1-800-FOR-TOMS (1-800-367-8667)

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

Active Ingredient (Active ingredient)

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Principal Display Panel 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)

THE ORIGINAL

Tom's

OF MAINE

ADA

Accepted

American

Dental

Association ®

NATURAL • WITH FLUORIDE

SIMPLY

WHITE®

anticavity toothpaste

CLEAN MINT

4.0 OZ (113 g)

CLINICALLY PROVEN

WHITENING

REMINERALIZES ENAMEL

PREVENTS CAVITIES

NO

ANIMAL TESTING,

ARTIFICIAL FLAVORS,

SWEETENERS OR DYES

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:12.486056 · Updated: 2026-03-14T23:10:26.709421