THERABREATH COMPLETE ORAL RINSE- anticavity oral rinse rinse

TheraBreath Complete Oral Rinse by

Drug Labeling and Warnings

TheraBreath Complete Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Applied Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Anticavity

USE

aids in the prevention of dental cavities

WARNING

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

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

THERABREATH COMPLETE ORAL RINSE 
anticavity oral rinse rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-267
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.002 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORITE (UNII: G538EBV4VF)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-267-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	12/31/2024

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		117337220	manufacture(10237-267)