Tom's

Tom's
SPL v1
SPL
SPL Set ID 7f20f8a0-75f9-4365-b00a-a53c6a35b448
Route
DENTAL
Published
Effective Date 2011-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.0076 g)
Inactive Ingredients
Glycerin Water Calcium Carbonate Hydrated Silica Xylitol Carrageenan Zinc Citrate Sodium Lauryl Sulfate Cinnamon Leaf Oil Clove Oil Clove Stem Oil Peppermint Oil Spearmint Oil Methyl Salicylate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-02-14
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) M - F 8:30 a.m. - 5:30 p.m. ET

Active Ingredient

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

Inactive Ingredients

glycerin, water, calcium carbonate, hydrated silica, xylitol, Chondrus crispus (carrageenan), sodium lauryl sulfate, sodium bicarbonate, zinc citrate, Cinnamomum cassia (cinnamon) leaf oil and other natural flavors.

Principal Display Panel 133 G Carton

Since 1970

Tom's

OF MAINE™

with fluoride | natural

WHOLE CARE ®

fights cavities | whitening | fresh breath | helps fight tartar

fluoride toothpaste

cinnamon clove

NET WT 4.7 OZ (133 g)

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) M - F 8:30 a.m. - 5:30 p.m. ET

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, Chondrus crispus (carrageenan), sodium lauryl sulfate, sodium bicarbonate, zinc citrate, Cinnamomum cassia (cinnamon) leaf oil and other natural flavors.

Principal Display Panel 133 G Carton (PRINCIPAL DISPLAY PANEL - 133 g Carton)

Since 1970

Tom's

OF MAINE™

with fluoride | natural

WHOLE CARE ®

fights cavities | whitening | fresh breath | helps fight tartar

fluoride toothpaste

cinnamon clove

NET WT 4.7 OZ (133 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:12.837194 · Updated: 2026-03-14T22:52:35.540850