Therabreath Plaque Control

Manufacturer: Church & Dwight Co., Inc.
Effective date: 2025-12-11
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:22:13

Label at a glance#

ProductTherabreath Plaque Control

Active ingredientCETYLPYRIDINIUM CHLORIDE

Label structure9 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

this rinse is not intended to replace brushing or flossing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.075%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

Stop use and ask a dentist if

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

this rinse is not intended to replace brushing or flossing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, poloxamer 407, flavor, sodium benzoate, sucralose

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

TB Plaque Control bottle label 72034417

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10237-259-16	Therabreath Plaque Control	473 mL in 1 BOTTLE, PLASTIC	RINSE	473	4
10237-259-26	Therabreath Plaque Control	473 mL in 1 BOTTLE, PLASTIC	RINSE	473	4
10237-259-26	Therabreath Plaque Control	2 in 1 BOX	RINSE	2	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Therabreath Plaque Control
CETYLPYRIDINIUM CHLORIDE
WATER
GLYCERIN
POLOXAMER 407
SODIUM BENZOATE
SUCRALOSE
CETYLPYRIDINIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10237-259	10237-259-16, 10237-259-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Therabreath Plaque Control	CETYLPYRIDINIUM CHLORIDE	Church & Dwight Co., Inc.	4987c71b-334d-4b20-bab4-b857e08a7383	2025-12-11	Warnings	Exact identifier ndc (package): 10237-259-26 ndc (package): 10237-259-16 ndc (product): 10237-259 ndc11 (package): 10237025926 ndc11 (package): 10237025916 spl id: 45b3634b-1017-96be-e063-6294a90aaa8c spl set id: 4987c71b-334d-4b20-bab4-b857e08a7383

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.