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
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

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

Description

Drug Facts

Questions?

1-800-FOR-TOMS M-F 8:30 a.m.-5 p.m. ET

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).

Active Ingredient

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

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

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)

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

Questions?

1-800-FOR-TOMS M-F 8:30 a.m.-5 p.m. ET

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).

Active Ingredient (Active ingredient)

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

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