Therabreath Complete Oral Rinse

Therabreath Complete Oral Rinse
SPL v2
SPL
SPL Set ID 27c33ae1-52c7-baad-e063-6394a90a0611
Route
ORAL
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.002 mg)
Inactive Ingredients
Sucralose Peg-40 Hydrogenated Castor Oil Sodium Bicarbonate Citric Acid Sodium Hydroxide Glycerin Water Sodium Chlorite Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-31

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

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 medical help or contact a Poison Control Center right away.

Section 51945-4

NO ALCOHOL,

NON BURNING

ANTICAVITY FLUORIDE RINSE

THERABREATH TM

DENTIST FORMULATED

COMPLETE

ORAL RINSE

6 BENEFITS IN 1

Fights Cavities • Freshens Breath

Kills Bad Breath Bacteria • Cleans Whole Mouth

Strengthens Teeth • Helps Rebuild Enamel

Dr. Harold Katz

REVITALIZING MINT

IMPORTANT: Read directions for proper use.

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

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, flavor, sodium benzoate, sucralose, sodium bicarbonate


Structured Label Content

Use (USE)

aids in the prevention of dental cavities

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)

NO ALCOHOL,

NON BURNING

ANTICAVITY FLUORIDE RINSE

THERABREATH TM

DENTIST FORMULATED

COMPLETE

ORAL RINSE

6 BENEFITS IN 1

Fights Cavities • Freshens Breath

Kills Bad Breath Bacteria • Cleans Whole Mouth

Strengthens Teeth • Helps Rebuild Enamel

Dr. Harold Katz

REVITALIZING MINT

IMPORTANT: Read directions for proper use.

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

Purpose (PURPOSE)

Anticavity

Directions (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, flavor, sodium benzoate, sucralose, sodium bicarbonate


Advanced Ingredient Data


Raw Label Data

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