THERABREATH DEEP CLEAN FRESH MINT- cetylpyridinium chloride rinse

Therabreath Deep Clean Fresh Mint by

Drug Labeling and Warnings

Therabreath Deep Clean Fresh 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

Cetylpyridinium Chloride 0.1%

Purpose

Antigingivitis/Antiplaque

Uses

• Helps prevent gingivitis, an early form of gum disease and bleeding gums
• Helps control plaque that leads to gingivitis and bleeding gums

Warnings

Stop use and ask a dentist if

• Gingivitis, bleeding, or redness persists for more than 2 weeks.
• You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and Children 12 years and older: Vigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
• Children 6 years to under 12 years: Supervise use.
• Children under 6 years: Do not use.

Other information

This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

Flavor, Glycerin, Poloxamer 407, Sucralose, Water

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

ALCOHOL
FREE

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

TheraBreath™

DENTIST FORMULATED

DEEP CLEAN

ORAL RINSE

KILLS 99.9% OF GERMS
THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS*

ANTISEPTIC

No Alcohol No Dyes Non Burning

FRESH MINT

16 fl.oz.
473 mL

INGREDIENTS AND APPEARANCE

THERABREATH DEEP CLEAN FRESH MINT 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-261
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	20 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-261-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/2024
2	NDC: 10237-261-03	88.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	505G(a)(3)	02/15/2024

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