Tom's

Tom's
SPL v1
SPL
SPL Set ID 9d334e5b-4879-4195-96aa-9bb8df26712b
Route
DENTAL
Published
Effective Date 2011-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (.0076 g)
Inactive Ingredients
Glycerin Water Calcium Carbonate Xylitol Hydrated Silica Carrageenan Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-05-06

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% (0.14% w/v fluoride ion)

Inactive Ingredients

glycerin, water, hydrated silica, calcium carbonate, xylitol, sodium lauryl sulfate, Mentha piperita (peppermint) oil and other natural flavors, Chondrus crispus (carrageenan), Glycyrrhiza uralensis (licorice) root extract.

Principal Display Panel 133 G Carton

SINCE 1970

Tom's

OF MAINE

long-lasting | natural

WICKED FRESH!™

cavity protection | fresh breath

fluoride toothpaste

cool peppermint

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% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

glycerin, water, hydrated silica, calcium carbonate, xylitol, sodium lauryl sulfate, Mentha piperita (peppermint) oil and other natural flavors, Chondrus crispus (carrageenan), Glycyrrhiza uralensis (licorice) root extract.

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

SINCE 1970

Tom's

OF MAINE

long-lasting | natural

WICKED FRESH!™

cavity protection | fresh breath

fluoride toothpaste

cool peppermint

NET WT 4.7 OZ (133 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)