Therabreath ™

Therabreath ™
SPL v4
SPL
SPL Set ID 578f8010-6b1c-4c6b-91d3-e483ace40f66
Route
ORAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.5 mg)
Inactive Ingredients
Water Glycerin Sodium Benzoate Citric Acid Monohydrate Sucralose Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01 Until 2025-05-04

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.

Section 51945-4

10237-257 Therabreath for Kids Anticavity Grapes Galore

Image of the carton label is not available as this product is no longer marketed.

Directions

Adults and children 6 years of age and older:

  • use once 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.

Other Information
  • Do not use if safety seal is broken or missing
Active Ingredients

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Inactive Ingredients

water, glycerin, sodium benzoate, flavor (organic), xylitol, citric acid, sucralose, sodium citrate

Principal Display Panel 473 Ml Bottle Label Wacky Watermelon

STRENGTHENS TEETH & ENAMEL

THERABREATH

KIDS

FOR AGES 6+

DENTIST FORMULATED

ANTICAVITY

FLUORIDE ORAL RINSE

Dr. Harold Katz

WACKY WATERMELON

16 fl. oz. (1 pt.) 473 mL

Principal Display Panel 473 Ml Bottle Label Strawberry Splash

STRENGTHENS TEETH & ENAMEL

THERABREATH

KIDS

FOR AGES 6+

DENTIST FORMULATED

ANTICAVITY

FLUORIDE ORAL RINSE

Dr. Harold Katz

16 fl. oz. (1 pt.) 473 mL

STRAWBERRY SPLASH


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.

Section 51945-4 (51945-4)

10237-257 Therabreath for Kids Anticavity Grapes Galore

Image of the carton label is not available as this product is no longer marketed.

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:

  • use once 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.

Other Information (Other information)
  • Do not use if safety seal is broken or missing
Active Ingredients

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Inactive Ingredients

water, glycerin, sodium benzoate, flavor (organic), xylitol, citric acid, sucralose, sodium citrate

Principal Display Panel 473 Ml Bottle Label Wacky Watermelon (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - WACKY WATERMELON)

STRENGTHENS TEETH & ENAMEL

THERABREATH

KIDS

FOR AGES 6+

DENTIST FORMULATED

ANTICAVITY

FLUORIDE ORAL RINSE

Dr. Harold Katz

WACKY WATERMELON

16 fl. oz. (1 pt.) 473 mL

Principal Display Panel 473 Ml Bottle Label Strawberry Splash (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - STRAWBERRY SPLASH)

STRENGTHENS TEETH & ENAMEL

THERABREATH

KIDS

FOR AGES 6+

DENTIST FORMULATED

ANTICAVITY

FLUORIDE ORAL RINSE

Dr. Harold Katz

16 fl. oz. (1 pt.) 473 mL

STRAWBERRY SPLASH


Advanced Ingredient Data


Raw Label Data

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