THERABREATH HEALTHY GUMS- cetylpyridinium chloride rinse

TheraBreath Healthy Gums by

Drug Labeling and Warnings

TheraBreath Healthy Gums 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 0.05%

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

Water, Glycerin, Poloxamer 407, Flavor, Sucralose

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

ANTIGINGIVITIS/ ANTIPLAQUE MOUTHRINSE

SAVE!
VALUE
SIZE

TheraBreath™

DENTIST FORMULATED

HEALTHY GUMS

ORAL RINSE

HELPS FIGHT GINGIVITIS FOR 24 HOURS*

HELPS REDUCE PLAQUE THAT LEADS TO GUM DISEASE

Reduces Occurrence of Bleeding Gums Freshens Breath
No Alcohol No Dyes Non Burning

CLEAN MINT

33.8 fl. oz.
1 liter

INGREDIENTS AND APPEARANCE

THERABREATH HEALTHY GUMS 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	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
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: 10237-258-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/13/2023
2	NDC: 10237-258-03	88.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/13/2023
3	NDC: 10237-258-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	505G(a)(3)	02/13/2023

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