tom whole care®

tom whole care®
SPL v1
SPL
SPL Set ID 08d7ed04-67a4-437a-82c5-496f9893c6c7
Route
dental
Published
Effective Date 2025-11-10
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 lauryl glucoside disodium cocoyl glutamate zinc citrate .iota.-carrageenan rebaudioside a sodium hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-12-01

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, lauryl glucoside, disodium cocoyl glutamate, zinc citrate, carrageenan, natural flavor

spearmint oil and other natural flavor
, rebaudioside A, sodium hydroxide.

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 contact Poison Control Center right away.

Active Ingredient

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

Principal Display Panel 113 G Tube Carton

NEW GREAT TASTE

THE ORIGINAL

Tom's

OF MAINE

NOT TESTED ON

ANIMALS

NATURAL • WITH FLUORIDE

WHOLE

CARE®

anticavity toothpaste

SPEARMINT

NET WT 4.0 OZ (113 g)

STRENGTHENS ENAMEL

PREVENTS CAVITIES

REMOVES STAINS*

NO

ANIMAL TESTING, SLS,

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)

glycerin, water, calcium carbonate, hydrated silica, xylitol, lauryl glucoside, disodium cocoyl glutamate, zinc citrate, carrageenan, natural flavor

spearmint oil and other natural flavor
, rebaudioside A, sodium hydroxide.

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 contact Poison Control Center right away.

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)

NEW GREAT TASTE

THE ORIGINAL

Tom's

OF MAINE

NOT TESTED ON

ANIMALS

NATURAL • WITH FLUORIDE

WHOLE

CARE®

anticavity toothpaste

SPEARMINT

NET WT 4.0 OZ (113 g)

STRENGTHENS ENAMEL

PREVENTS CAVITIES

REMOVES STAINS*

NO

ANIMAL TESTING, SLS,

ARTIFICIAL FLAVORS,

SWEETENERS OR DYES


Advanced Ingredient Data


Raw Label Data

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