tom's®

tom's®
SPL v7
SPL
SPL Set ID fdbadaae-eab7-4d9a-acf7-815ca93f877c
Route
dental
Published
Effective Date 2024-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.4 mg)
Inactive Ingredients
glycerin water calcium carbonate hydrated silica xylitol peppermint oil sodium lauryl sulfate carrageenan zinc citrate sodium bicarbonate benzyl alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2014-06-06 Until 2021-04-01
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

glycerin, water, calcium carbonate, hydrated silica, xylitol, natural flavor

peppermint oil and other natural flavor
, sodium lauryl sulfate, carrageenan, zinc citrate, sodium bicarbonate, benzyl alcohol.

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 monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Principal Display Panel 113 G Tube Carton

THE ORIGINAL

Tom's

OF MAINE

• NOT TESTED ON

ANIMALS •

NATURAL • WITH FLUORIDE

WHOLE

CARE®

anticavity toothpaste

PEPPERMINT

STRENGTHENS ENAMEL

PREVENTS CAVITIES

WHITENS TEETH*

NO

ANIMAL TESTING,

ARTIFICIAL FLAVORS,

SWEETENERS OR DYES

4.0 OZ (113 g)

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)

glycerin, water, calcium carbonate, hydrated silica, xylitol, natural flavor

peppermint oil and other natural flavor
, sodium lauryl sulfate, carrageenan, zinc citrate, sodium bicarbonate, benzyl alcohol.

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 monofluorophosphate 0.76% (0.13% w/v fluoride ion)

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

THE ORIGINAL

Tom's

OF MAINE

• NOT TESTED ON

ANIMALS •

NATURAL • WITH FLUORIDE

WHOLE

CARE®

anticavity toothpaste

PEPPERMINT

STRENGTHENS ENAMEL

PREVENTS CAVITIES

WHITENS TEETH*

NO

ANIMAL TESTING,

ARTIFICIAL FLAVORS,

SWEETENERS OR DYES

4.0 OZ (113 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:31.488737 · Updated: 2026-03-14T23:05:20.270582