THERABREATH OVERNIGHT CHAMOMILE MINT- sodium fluoride rinse

Therabreath Overnight Chamomile Mint by

Drug Labeling and Warnings

Therabreath Overnight Chamomile Mint 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 Ingredients

Sodium Fluoride 0.05% (0.02% wh fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Keep out of the reach of children.If more than used for rinsing is accidentally swallowed, gel medical help or contact a Poison Control Center right away.

Do not usewith another fluoride rinse on the same day.

Directions

Adults 18 years of age or older:

• Use once a day atter 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, Flavor, Citric Acid, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Sodium Bicarbonate, Sodium Chlorite, Sodium Hydroxide, Sucralose

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

ANTICAVITY FLUORIDE RINSE

STRENGTHENS
TEETH

TheraBreath ™
DENTIST FORMULATED
OVERNIGHT
ORAL RINSE

FIGHTS BAD BREATH FOR 12 HOURS*
HELPS PREVENT CAVITIES & REBUILD ENAMEL

No Alcohol No Dyes
Non Burning

IMPORTANT:
Read directions
for proper use.

16 fl. oz.
473 mL

CHAMOMILE MINT

INGREDIENTS AND APPEARANCE

THERABREATH OVERNIGHT CHAMOMILE MINT 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	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	MENTHOL, MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-262-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/22/2024
2	NDC: 10237-262-26	2 in 1 PACKAGE	01/22/2024
2		473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

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