Toms®

Toms®
SPL v6
SPL
SPL Set ID ebb62015-0027-459a-a9cf-56b640f9f456
Route
DENTAL
Published
Effective Date 2024-10-15
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 Sodium Lauryl Sulfate Spearmint Oil Carrageenan Peppermint Oil Zinc Citrate Sodium Bicarbonate Benzyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-06-06 Until 2021-03-05
Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

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).

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
Questions?

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

Active Ingredient

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

Inactive Ingredients

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

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

Principal Display Panel 113 G Tube Carton

THE ORIGINAL

Tom's

OF MAINE

• NOT TESTED ON •

ANIMALS

NATURAL • WITH FLUORIDE

WHOLE

CARE®

anticavity toothpaste

SPEARMINT

4.0 OZ (113 g)

STRENGTHENS ENAMEL

PREVENTS CAVITIES

WHITENS TEETH*

NO

ANIMAL TESTING,

ARTIFICIAL FLAVORS,

SWEETENERS OR DYES

Structured Label Content

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).

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
Questions?

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

Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

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

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

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

SPEARMINT

4.0 OZ (113 g)

STRENGTHENS ENAMEL

PREVENTS CAVITIES

WHITENS TEETH*

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: 2026-02-15T12:04:27.524540 · Updated: 2026-03-14T23:05:12.885917