Tom's Whole Care®

Tom's Whole Care®
SPL v6
SPL
SPL Set ID 3e7ab39a-989c-4924-af3e-689404912bee
Route
DENTAL
Published
Effective Date 2022-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.4 mg)
Inactive Ingredients
Glycerin Water Calcium Carbonate Hydrated Silica Xylitol Sodium Lauryl Sulfate Carrageenan Sodium Bicarbonate Zinc Citrate Cinnamon Leaf Oil Orange Oil, Cold Pressed Clove Oil Clove Stem Oil Benzyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-07-12 Until 2021-02-07

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)

Active Ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Inactive Ingredients

glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium lauryl sulfate, carrageenan, zinc citrate, sodium bicarbonate, natural flavor

cinnamon oil and other natural flavor
, benzyl alcohol.

Principal Display Panel 113 G Tube Carton

Certified

B®

Corporation

THE ORIGINAL

Tom's

OF MAINE

4.0 OZ (113 g)

NEW

LOOK

NATURAL • WITH FLUORIDE

WHOLE

CARE

anticavity toothpaste

6

BENEFITS FOR HEALTHY TEETH

6 BENEFITS

• fights cavities

• whitens teeth*

• fights tartar buildup

• freshens breath

• strengthens enamel

• promotes

remineralization

CINNAMON CLOVE


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)

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium lauryl sulfate, carrageenan, zinc citrate, sodium bicarbonate, natural flavor

cinnamon oil and other natural flavor
, benzyl alcohol.

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

Certified

B®

Corporation

THE ORIGINAL

Tom's

OF MAINE

4.0 OZ (113 g)

NEW

LOOK

NATURAL • WITH FLUORIDE

WHOLE

CARE

anticavity toothpaste

6

BENEFITS FOR HEALTHY TEETH

6 BENEFITS

• fights cavities

• whitens teeth*

• fights tartar buildup

• freshens breath

• strengthens enamel

• promotes

remineralization

CINNAMON CLOVE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)