THERABREATH ANTICAVITY- sodium fluoride rinse

TheraBreath Anticavity by

Drug Labeling and Warnings

TheraBreath Anticavity by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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, 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

INGREDIENTS AND APPEARANCE

THERABREATH ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-265
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORITE (UNII: G538EBV4VF)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
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: 10237-265-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	08/15/2024

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