tom's whole care®

tom's whole care®
SPL v10
SPL
SPL Set ID 6875f5c1-853c-43da-8226-c09a5518f9bb
Route
dental
Published
Effective Date 2022-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1 mg)
Inactive Ingredients
water glycerin propanediol xylitol sodium phosphate, dibasic, anhydrous benzoic acid aloe vera leaf sorbitol phosphoric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-12-08
Purpose

Anticavity

Description

Drug Facts

Medication Information

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Inactive Ingredients

water, glycerin, sorbitol, Aloe barbadensis leaf juice

organic
, propanediol, xylitol, natural flavor, benzoic acid, phosphoric acid, disodium phosphate

Description

Drug Facts

Questions?

1-800-FOR-TOMS (1-800-367-8667)

Use

aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Active Ingredient (in Each 10 Ml)

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Principal Display Panel 473 Ml Bottle Label

Certified

B®

Corporation

NEW

LOOK

THE ORIGINAL

Tom's

OF MAINE

NATURAL • WITH FLUORIDE

WHOLE CARE®

anticavity mouthwash

6 • BENEFITS FOR HEALTHY TEETH

6 BENEFITS

  • fights cavities
  • freshens breath
  • restores minerals
  • strengthens enamel
  • cleans between teeth
  • alcohol-free

FRESH MINT

16 FL OZ (473 mL)

IMPORTANT: Read

directions for proper use

PS0022908

Structured Label Content

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Inactive Ingredients (Inactive ingredients)

water, glycerin, sorbitol, Aloe barbadensis leaf juice

organic
, propanediol, xylitol, natural flavor, benzoic acid, phosphoric acid, disodium phosphate

Questions?

1-800-FOR-TOMS (1-800-367-8667)

Use

aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Active Ingredient (in Each 10 Ml) (Active ingredient (in each 10 mL))

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

Certified

B®

Corporation

NEW

LOOK

THE ORIGINAL

Tom's

OF MAINE

NATURAL • WITH FLUORIDE

WHOLE CARE®

anticavity mouthwash

6 • BENEFITS FOR HEALTHY TEETH

6 BENEFITS

  • fights cavities
  • freshens breath
  • restores minerals
  • strengthens enamel
  • cleans between teeth
  • alcohol-free

FRESH MINT

16 FL OZ (473 mL)

IMPORTANT: Read

directions for proper use

PS0022908

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.423293 · Updated: 2026-03-14T23:02:25.522673