natural fluoride toothpaste, fresh mint

natural fluoride toothpaste, fresh mint
SPL v5
SPL
SPL Set ID fce5e8b5-34f8-4a45-a662-82c903419809
Route
dental
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.00243 g)
Inactive Ingredients
sorbitol water hydrated silica glycerin xylitol sodium lauryl sulfate peppermint oil xanthan gum titanium dioxide carrageenan

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2012-09-01 Until 2028-12-31

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 flavor

Peppermint oil and other natural flavor
, xanthan gum, titanium dioxide, carrageenan.

Description

Drug Facts

Questions?

1-800-FOR-TOMS (1-800-367-8667) 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 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 85 G Tube Label

THE ORIGINAL

Tom's

OF MAINE

BEAUTIFUL SMILE.

BEAUTIFUL PLANET.

3.0 OZ (85 g)

NATURAL

WITH FLUORIDE

anticavity toothpaste

whitening ∙ freshens breath

fresh mint


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 flavor

Peppermint oil and other natural flavor
, xanthan gum, titanium dioxide, carrageenan.

Questions?

1-800-FOR-TOMS (1-800-367-8667) 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 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 85 G Tube Label (PRINCIPAL DISPLAY PANEL - 85 g Tube Label)

THE ORIGINAL

Tom's

OF MAINE

BEAUTIFUL SMILE.

BEAUTIFUL PLANET.

3.0 OZ (85 g)

NATURAL

WITH FLUORIDE

anticavity toothpaste

whitening ∙ freshens breath

fresh mint


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)