THERABREATH AM-PM TWIN PACK- sodium fluoride kit

TheraBreath by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Overnight Oral Rinse

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

WARNINGS

Warning

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

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

INGREDIENTS AND APPEARANCE

THERABREATH  AM-PM TWIN PACK
sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-268

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-268-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	02/03/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	473 mL
Part 2	1 BOTTLE, PLASTIC	473 mL

Part 1 of 2

THERABREATH OVERNIGHT CHAMOMILE MINT 
sodium fluoride rinse

Product Information
Item Code (Source)	NDC: 10237-262
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	5 mg  in 10 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		473 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/22/2024

Part 2 of 2

THERABREATH FRESH BREATH ORAL RINSE INVIGORATING ICY MINT 
mouthwashes and breath fresheners (liquids and sprays) [oral products] liquid

Product Information
Route of Administration	ORAL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		473 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	02/03/2025

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