Tom's

Tom's
SPL v2
SPL
SPL Set ID f1cba5ce-852e-424a-b274-4a514505156b
Route
DENTAL
Published
Effective Date 2011-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.0076 g)
Inactive Ingredients
Calcium Carbonate Glycerin Water Sodium Bicarbonate Carrageenan Xylitol Sodium Lauryl Sulfate Peppermint Oil Spearmint Oil

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% (0.15% w/v fluoride ion)

Inactive Ingredients

calcium carbonate, water, glycerin, sodium bicarbonate, Chondrus crispus (carrageenan), Mentha piperita (peppermint) oil, xylitol, sodium lauryl sulfate.

Principal Display Panel 155.9 G Carton

SINCE 1970

Tom's

OF MAINE

baking soda ∣ natural

CAVITY PROTECTION

fights cavities ∣ fresh breath

fluoride toothpaste

peppermint

ADA

Accepted


American

Dental

Association ®

NET WT 5.5 OZ (155.9 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% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

calcium carbonate, water, glycerin, sodium bicarbonate, Chondrus crispus (carrageenan), Mentha piperita (peppermint) oil, xylitol, sodium lauryl sulfate.

Principal Display Panel 155.9 G Carton (PRINCIPAL DISPLAY PANEL - 155.9 g Carton)

SINCE 1970

Tom's

OF MAINE

baking soda ∣ natural

CAVITY PROTECTION

fights cavities ∣ fresh breath

fluoride toothpaste

peppermint

ADA

Accepted


American

Dental

Association ®

NET WT 5.5 OZ (155.9 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)