therabreath ™

therabreath ™
SPL v4
SPL
SPL Set ID cc0c533c-145e-4877-b421-1baf3a3a572e
Route
oral
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (5 mg)
Inactive Ingredients
water glycerin sodium benzoate sodium hydroxide sodium chlorite citric acid monohydrate sucralose polyoxyl 40 hydrogenated castor oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-01-22
Purpose

Anticavity

Description

Drug Facts

Medication Information

Purpose

Anticavity

Directions

Adults 18 years of age or older:

  • Use once a day atter 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.
Other Information

Do not use if safety seal is broken or missing

Inactive Ingredients

Water, Flavor, Citric Acid, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Sodium Bicarbonate, Sodium Chlorite, Sodium Hydroxide, Sucralose

Description

Drug Facts

Use

Aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children.If more than used for rinsing is accidentally swallowed, gel medical help or contact a Poison Control Center right away.

Section 50570-1

Do not usewith another fluoride rinse on the same day.

Active Ingredients

Sodium Fluoride 0.05% (0.02% wh fluoride ion)

Principal Display Panel 473 Ml Bottle Label

ANTICAVITY FLUORIDE RINSE

STRENGTHENS

TEETH

TheraBreath ™

DENTIST FORMULATED

OVERNIGHT

ORAL RINSE

FIGHTS BAD BREATH FOR 12 HOURS*

HELPS PREVENT CAVITIES & REBUILD ENAMEL

No Alcohol • No Dyes

Non Burning

IMPORTANT:

Read directions

for proper use.

16 fl. oz.

473 mL

CHAMOMILE MINT

Structured Label Content

Purpose

Anticavity

Directions

Adults 18 years of age or older:

  • Use once a day atter 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.
Other Information (Other information)

Do not use if safety seal is broken or missing

Inactive Ingredients

Water, Flavor, Citric Acid, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Sodium Bicarbonate, Sodium Chlorite, Sodium Hydroxide, Sucralose

Use

Aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children.If more than used for rinsing is accidentally swallowed, gel medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not usewith another fluoride rinse on the same day.

Active Ingredients

Sodium Fluoride 0.05% (0.02% wh fluoride ion)

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

ANTICAVITY FLUORIDE RINSE

STRENGTHENS

TEETH

TheraBreath ™

DENTIST FORMULATED

OVERNIGHT

ORAL RINSE

FIGHTS BAD BREATH FOR 12 HOURS*

HELPS PREVENT CAVITIES & REBUILD ENAMEL

No Alcohol • No Dyes

Non Burning

IMPORTANT:

Read directions

for proper use.

16 fl. oz.

473 mL

CHAMOMILE MINT

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:37.759171 · Updated: 2026-03-14T23:11:16.641314