THERABREATH- cetylpyridinium chloride 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]

SPL UNCLASSIFIED SECTION

TheraBreath Healthy Gums + Deep Clean Variety Pack

Drug Facts

TheraBreath Healthy Gums Oral Rinse

Active ingredient

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis/Antiplaque

Uses

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

WARNINGS

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 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

do not use both oral rinses together.

Inactive ingredients

water, glycerin, poloxamer 407, flavor, sucralose

QUESTIONS

Church & Dwight Co., Inc.

PHONE: 1-800-973-7374

WEB: THERABREATH.COM

Drug Facts

TheraBreath Deep Clean Oral Rinse

Active Ingredient

Cetylpyridinium chloride 0.1%

Purpose

Antigingivitis/Antiplaque

Uses

helps prevent gingivitis, an early form of gum disease bleeding gums
helps control plaque that leads to gingivitus bleeding gums

WARNINGS

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 reachof 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

do not use both oral rinses together.

Inactive ingredients

water, glycerin, poloxamer 407, flavor, sucralose

QUESTIONS

Church & Dwight Co., Inc.

PHONE: 1-800-973-7374

WEB: THERABREATH.COM

Principal Display Panel

TheraBreath TM

HEALTHY GUMS + DEEP CLEAN

ANTIGINGIVITIS/ANTIPLAQUE VARIETY PACK

Add TheraBreath to your swishy time routine for healthy gums or a deep clean

Helps fight gingivitis for 12 hours

Kills 99.9% of germs that cause bad breath, plaque & gingivitis*

*in laboratory tests

TheraBreath HEALTHY GUMS CLEAN MINT

TheraBreath DEEP CLEAN FRESH MINT

2 BOTTLES 16 FL OZ (1 PT) 473 mL each; 32 FL OZ (1 qt) 946 mL TOTAL

INGREDIENTS AND APPEARANCE

THERABREATH 
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-269

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-269-01	1 in 1 CARTON	01/01/2026

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 DEEP CLEAN FRESH MINT 
cetylpyridinium chloride rinse

Product Information
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)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)

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

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

Part 2 of 2

THERABREATH HEALTHY GUMS 
cetylpyridinium chloride rinse

Product Information
Item Code (Source)	NDC: 10237-258
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.01 mg  in 20 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-258-16	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	505G(a)(3)	02/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/01/2026

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