Tom's™

Tom's™
SPL v1
SPL
SPL Set ID b31e5464-220b-4e6b-b71b-a0eb05418b42
Route
DENTAL
Published
Effective Date 2010-08-24
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 Strawberry Carrageenan Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-08-30

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, natural flavors, Chondrus crispus (carrageenan), sodium lauryl sulfate.

Principal Display Panel 24.7 G Carton

SINCE 1970

Tom's


OF MAINE

natural

children's

prevents cavities, tastes great

fluoride toothpaste

silly strawberry

ADA

Accepted


American

Dental

Association ®

NET WT .87 OZ (24.7 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, natural flavors, Chondrus crispus (carrageenan), sodium lauryl sulfate.

Principal Display Panel 24.7 G Carton (PRINCIPAL DISPLAY PANEL - 24.7 g Carton)

SINCE 1970

Tom's


OF MAINE

natural

children's

prevents cavities, tastes great

fluoride toothpaste

silly strawberry

ADA

Accepted


American

Dental

Association ®

NET WT .87 OZ (24.7 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)