tom's wicked fresh!®

tom's wicked fresh!®
SPL v5
SPL
SPL Set ID b9962eac-186e-4da2-929d-393f18ed0234
Route
dental
Published
Effective Date 2023-10-04
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 xylitol hydrated silica sodium lauryl sulfate carrageenan benzyl alcohol licorice

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2014-06-06 Until 2025-06-08

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, xylitol, hydrated silica, sodium lauryl sulfate, natural flavor

spearmint oil and other natural flavor
, carrageenan, benzyl alcohol, Glycyrrhiza glabra (Licorice) root extract.

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

WICKED

FRESH!®

anticavity toothpaste

SPEARMINT ICE

4.0 OZ (113 g)

CLINICALLY PROVEN

TO FRESHEN BREATH

FIGHTS CAVITIES

BLOCKS BAD BREATH

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)

glycerin, water, calcium carbonate, xylitol, hydrated silica, sodium lauryl sulfate, natural flavor

spearmint oil and other natural flavor
, carrageenan, benzyl alcohol, Glycyrrhiza glabra (Licorice) root extract.

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

WICKED

FRESH!®

anticavity toothpaste

SPEARMINT ICE

4.0 OZ (113 g)

CLINICALLY PROVEN

TO FRESHEN BREATH

FIGHTS CAVITIES

BLOCKS BAD BREATH

NO

ANIMAL TESTING,

ARTIFICIAL FLAVORS,

SWEETENERS OR DYES


Advanced Ingredient Data


Raw Label Data

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