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 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, Sodium Benzoate, Sucralose

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

WITH
50% MORE
CPC ‡

TheraBreath ™

DENTIST FORMULATED

PLAQUE CONTROL

PRE-BRUSH

ORAL RINSE

HELPS FIGHT PLAQUE & GINGIVITIS FOR 24 HOURS*

ANTI-BACTERIAL RINSE CLEANS WHOLE MOUTH

No Alcohol No Dyes Non Burning

COOL MINT

16 fl. oz.
473 mL

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)