Tom's Luminous White Fluoride Clean Mint

Tom's Luminous White Fluoride Clean Mint
SPL v9
SPL
SPL Set ID 7d0bc7be-da6e-4c24-9be9-8a0b40f27960
Route
DENTAL
Published
Effective Date 2022-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.00243 g)
Inactive Ingredients
Hydrated Silica Water Glycerin Sorbitol Xylitol Sodium Lauryl Sulfate Peppermint Oil Xanthan Gum Titanium Dioxide Carrageenan

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-12-01 Until 2026-10-01

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.

Active Ingredient

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

Inactive Ingredients

water, hydrated silica, glycerin, sorbitol, xylitol, sodium lauryl sulfate, natural flavor

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

Principal Display Panel 113 G Tube Label

THE ORIGINAL

Tom's

OF MAINE

BEAUTIFUL SMILE.

BEAUTIFUL PLANET.

LUMINOUS

WHITE

4.0 OZ (113 g)


Structured Label Content

Use (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 (purpose)

anticavity

Directions (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.

Active Ingredient (active ingredient)

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

Inactive Ingredients (inactive ingredients)

water, hydrated silica, glycerin, sorbitol, xylitol, sodium lauryl sulfate, natural flavor

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

Principal Display Panel 113 G Tube Label (PRINCIPAL DISPLAY PANEL - 113 g Tube Label)

THE ORIGINAL

Tom's

OF MAINE

BEAUTIFUL SMILE.

BEAUTIFUL PLANET.

LUMINOUS

WHITE

4.0 OZ (113 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)