THERABREATH PLAQUE CONTROL- cetylpyridinium chloride rinse 
Church & Dwight Co., Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Therabreath Plaque Control

Drug Facts

Active Ingredient

Cetylpyridinium Chloride 0.075%

Purpose

Antigingivitis/Antiplaque

Uses

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 olderVigorously 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 yearsSupervise use.
Children under 6 yearsDo 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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
THERABREATH PLAQUE CONTROL 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-259
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.015 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-259-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35604/25/2023
Labeler - Church & Dwight Co., Inc. (001211952)

Revised: 7/2023
Document Id: f62c2212-b79f-421e-87c2-fb59afa9e71f
Set id: 4987c71b-334d-4b20-bab4-b857e08a7383
Version: 1
Effective Time: 20230705
 
Church & Dwight Co., Inc.