tom's®

tom's®
SPL v3
SPL
SPL Set ID d5e1396e-0253-4ec0-a9ff-b61bda70de35
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 xanthan gum sorbitol carrageenan zinc citrate titanium dioxide xylitol hydrated silica methyl salicylate sodium lauryl sulfate water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2018-11-19
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, hydrated silica, sorbitol, xylitol, glycerin, natural flavor

wintergreen oil and other natural flavor
, sodium lauryl sulfate, zinc citrate, xanthan gum, titanium dioxide, carrageenan.

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% (0.14% 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

WINTERMINT

4.0 OZ (113 g)

STRENGTHENS ENAMEL

PREVENTS CAVITIES

WHITENS TEETH*

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, hydrated silica, sorbitol, xylitol, glycerin, natural flavor

wintergreen oil and other natural flavor
, sodium lauryl sulfate, zinc citrate, xanthan gum, titanium dioxide, carrageenan.

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% (0.14% 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

WINTERMINT

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: 2026-02-15T12:04:30.076758 · Updated: 2026-03-14T23:05:17.700396