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SPL v1

SPL

SPL Set ID 4618e390-9039-a1d0-e063-6294a90ab294

Route

ORAL

Published

Effective Date 2025-12-16

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 2025-02-03

Description

Overnight Oral Rinse

Purpose

Anticavity

Medication Information

Warnings and Precautions

Warning

Purpose

Anticavity

Description

Overnight Oral Rinse

Use

aids in the prevention of dental cavities

Section 50565-1

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

Directions

Adults 18 years of age or 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 30 minutes after rinsing

Drug Facts

Overnight Oral Rinse

Active Ingredient

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

Inactive Ingredients

water, glycerin, PEG-40 hyrogenated castor oil, citric acid, menthol, sodium benzoate, sodium bicarbonate, sodium chlorite, sodium hydroxide, sucralose, flavor

Principal Display Panel

TheraBreath AM + PM TWIN PACK

INVIGORATING ICY MINT

ANTICAVITY FLUORIDE RINSE

CHAMOMILE MINT

Helps prvent cavities and rebuild enamel

Add TheraBreath to your swishy time routine both day + night!

Fights bad breath for 12 hours

Structured Label Content

Use

aids in the prevention of dental cavities

Warnings and Precautions (34071-1)

Warning

Section 50565-1 (50565-1)

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

Purpose

Anticavity

Directions

Adults 18 years of age or 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 30 minutes after rinsing

Drug Facts

Overnight Oral Rinse

Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, PEG-40 hyrogenated castor oil, citric acid, menthol, sodium benzoate, sodium bicarbonate, sodium chlorite, sodium hydroxide, sucralose, flavor

Principal Display Panel

TheraBreath AM + PM TWIN PACK

INVIGORATING ICY MINT

ANTICAVITY FLUORIDE RINSE

CHAMOMILE MINT

Helps prvent cavities and rebuild enamel

Add TheraBreath to your swishy time routine both day + night!

Fights bad breath for 12 hours

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "34071-1": "Warning", "50565-1": "Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get help or contact a Poison Control Center right away.", "Purpose": "Anticavity", "Directions": "Adults 18 years of age or 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 30 minutes after rinsing", "Drug Facts": "Overnight Oral Rinse", "Active ingredient": "Sodium fluoride 0.05% (0.02% w/v fluoride ion)", "Inactive ingredients": "water, glycerin, PEG-40 hyrogenated castor oil, citric acid, menthol, sodium benzoate, sodium bicarbonate, sodium chlorite, sodium hydroxide, sucralose, flavor", "Principal Display Panel": "TheraBreath AM + PM TWIN PACK AM POWERED BY OXYGEN TM INVIGORATING ICY MINT PM ANTICAVITY FLUORIDE RINSE CHAMOMILE MINT Helps prvent cavities and rebuild enamel Add TheraBreath to your swishy time routine both day + night! Fights bad breath for 12 hours"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:44.159548 · Updated: 2026-03-14T23:11:28.912883