Simply White®

Simply White®
SPL v2
SPL
SPL Set ID 350597b0-c2a0-4d9a-89d3-4c5930f4909c
Route
DENTAL
Published
Effective Date 2011-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.0024 g)
Inactive Ingredients
Sorbitol Water Silicon Dioxide Glycerin Xylitol Sodium Lauryl Sulfate Menthol Xanthan Gum Peppermint Oil Carrageenan Spearmint Oil Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-02-04
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 the 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 M-F 8:30 a.m.-5 p.m. ET

Active Ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients

hydrated silica, water, sorbitol, glycerin, xylitol, sodium lauryl sulfate, natural flavors, xanthan gum, titanium dioxide, Chondrus crispus (carrageenan).

Principal Display Panel 133.2g Tube Carton

new!

SINCE 1970

Tom's

OF MAINE™

natural

SIMPLY WHITE®

whitening | cavity protection | fresh breath

fluoride toothpaste

clean mint

NET WT 133.2g (4.7 OZ)

Structured Label Content

Use

helps protect against cavities.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the 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 M-F 8:30 a.m.-5 p.m. ET

Active Ingredient (Active ingredient)

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

hydrated silica, water, sorbitol, glycerin, xylitol, sodium lauryl sulfate, natural flavors, xanthan gum, titanium dioxide, Chondrus crispus (carrageenan).

Principal Display Panel 133.2g Tube Carton (PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton)

new!

SINCE 1970

Tom's

OF MAINE™

natural

SIMPLY WHITE®

whitening | cavity protection | fresh breath

fluoride toothpaste

clean mint

NET WT 133.2g (4.7 OZ)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:13.412416 · Updated: 2026-03-14T22:52:36.393397