Therabreath ™

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.002 mg)

Inactive Ingredients

Water Glycerin Polyoxyl 40 Hydrogenated Castor Oil Citric Acid Monohydrate Sodium Hydroxide Sodium Chlorite Menthol, Unspecified Form Lemon Oil, Cold Pressed Peppermint Oil Sodium Benzoate Sucralose Xylitol Sodium Bicarbonate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-08-15

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 18 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

Active Ingredient

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

Other Information

do not use if safety seal is broken or missing

Inactive Ingredients

water, glycerin, PEG-40 hydrogenated castor oil, citric acid, sodium hydroxide, sodium chlorite, menthol, citrus lemon peel oil, Mentha piperita oil, sodium benzoate, sucralose, xylitol, sodium bicarbonate

Principal Display Panel 1 L Bottle Label

ANTICAVITY FLUORIDE RINSE

USE 2X

DAILY

TheraBreath _™

DENTIST FORMULATED

ANTICAVITY

ORAL RINSE

HELPS FIGHT CAVITIES FOR 24 HOURS*

STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH

Helps rebuild weakened tooth enamel and prevent tooth decay

No Alcohol • With Fluoride • Non-Burning

Sodium Fluoride 0.02%

IMPORTANT:

Read directions for proper use.

33.8 FL OZ

(1.05 QT) 1 L

SPARKLE MINT

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 18 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

Active Ingredient (Active ingredient)

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

Other Information (Other information)

do not use if safety seal is broken or missing

Inactive Ingredients (Inactive ingredients)

water, glycerin, PEG-40 hydrogenated castor oil, citric acid, sodium hydroxide, sodium chlorite, menthol, citrus lemon peel oil, Mentha piperita oil, sodium benzoate, sucralose, xylitol, sodium bicarbonate

Principal Display Panel 1 L Bottle Label (PRINCIPAL DISPLAY PANEL - 1 L Bottle Label)

ANTICAVITY FLUORIDE RINSE

USE 2X

DAILY

TheraBreath _™

DENTIST FORMULATED

ANTICAVITY

ORAL RINSE

HELPS FIGHT CAVITIES FOR 24 HOURS*

STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH

Helps rebuild weakened tooth enamel and prevent tooth decay

No Alcohol • With Fluoride • Non-Burning

Sodium Fluoride 0.02%

IMPORTANT:

Read directions for proper use.

33.8 FL OZ

(1.05 QT) 1 L

SPARKLE MINT

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORITE", "unii": "G538EBV4VF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEMON OIL, COLD PRESSED", "unii": "I9GRO824LL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.002", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "42229-5": "Drug Facts", "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 18 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", "Active ingredient": "Sodium fluoride 0.02% (0.01% w/v fluoride ion)", "Other information": "do not use if safety seal is broken or missing", "Inactive ingredients": "water, glycerin, PEG-40 hydrogenated castor oil, citric acid, sodium hydroxide, sodium chlorite, menthol, citrus lemon peel oil, Mentha piperita oil, sodium benzoate, sucralose, xylitol, sodium bicarbonate", "PRINCIPAL DISPLAY PANEL - 1 L Bottle Label": "ANTICAVITY FLUORIDE RINSE USE 2X DAILY TheraBreath ™ DENTIST FORMULATED ANTICAVITY ORAL RINSE HELPS FIGHT CAVITIES FOR 24 HOURS* STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH Helps rebuild weakened tooth enamel and prevent tooth decay No Alcohol • With Fluoride • Non-Burning Sodium Fluoride 0.02% IMPORTANT: Read directions for proper use. 33.8 FL OZ (1.05 QT) 1 L SPARKLE MINT"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information