Tom's Children's Anticavity Mouthwash Silly Strawberry

Tom's Children's Anticavity Mouthwash Silly Strawberry
SPL v10
SPL
SPL Set ID 998c6f35-20f4-4cb8-bc48-6aa39e61481a
Route
DENTAL
Published
Effective Date 2022-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2 mg)
Inactive Ingredients
Water Glycerin Propanediol Xylitol Sodium Phosphate Benzoic Acid Aloe Vera Leaf Levomenthol Phosphoric Acid Strawberry Juice Pineapple Juice Orange Juice Lemon Juice Mango Juice Rebaudioside A

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-18

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

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

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

Questions?

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

Inactive Ingredients

water, glycerin, Aloe barbadensis leaf juice

organic
, xylitol, sodium phosphate, propanediol, benzoic acid, natural flavor, phosphoric acid, menthol, Fragaria ananassa (Strawberry) fruit juice, Ananas sativus (Pineapple) fruit juice, Citrus aurantium dulcis (Orange) juice, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Rebaudioside A

Active Ingredient (in Each 10ml)

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

Principal Display Panel 473 Ml Bottle Label

SINCE 1970

Tom's

OF MAINE®

alcohol-free | natural

children's anticavity

fluoride rinse

cavity protection for

a healthy smile

tastes great

dye free

ADA

Accepted

American

Dental

Association®

silly

strawberry

16 FL OZ (473 mL)

with real

fruit juice!

P9937074

IMPORTANT: Read

directions for proper use


Structured Label Content

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

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

Questions?

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, Aloe barbadensis leaf juice

organic
, xylitol, sodium phosphate, propanediol, benzoic acid, natural flavor, phosphoric acid, menthol, Fragaria ananassa (Strawberry) fruit juice, Ananas sativus (Pineapple) fruit juice, Citrus aurantium dulcis (Orange) juice, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Rebaudioside A

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

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

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

SINCE 1970

Tom's

OF MAINE®

alcohol-free | natural

children's anticavity

fluoride rinse

cavity protection for

a healthy smile

tastes great

dye free

ADA

Accepted

American

Dental

Association®

silly

strawberry

16 FL OZ (473 mL)

with real

fruit juice!

P9937074

IMPORTANT: Read

directions for proper use


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)