THERABREATH PLAQUE CONTROL- cetylpyridinium chloride rinse

Therabreath Plaque Control by

Drug Labeling and Warnings

Therabreath Plaque Control 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 Ingredient

Cetylpyridinium Chloride 0.075%

Purpose

Antigingivitis/Antiplaque

Uses

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

USE BEFORE BRUSHING

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

TheraBreath ™

DENTIST FORMULATED

PLAQUE CONTROL

PRE-BRUSH

ORAL RINSE

HELPS FIGHT PLAQUE & GINGIVITIS FOR 12 HOURS*

Helps reduce gingivitis, an early form of gum disease

ANTI-BACTERIAL RINSE CLEANS WHOLE MOUTH

No Alcohol No Dyes Non Burning

REFRESHING MINT

16 fl. oz.
473 mL

*As part of an oral care routine.

INGREDIENTS AND APPEARANCE

THERABREATH PLAQUE CONTROL 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-259
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.015 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
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: 10237-259-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/25/2023
2	NDC: 10237-259-26	2 in 1 BOX	01/01/2025
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	505G(a)(3)	04/25/2023

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