THERABREATH HEALTHY GUMS ORAL RINSE- cetylpyridinium chloride rinse 
Dr. Harold Katz, LLC

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 Healthy Gums Oral Rinse

Active Ingredient

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis/Antiplaque

Uses

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

Warnings

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.

Warnings

Stop Use and Ask a Doctor If

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 under12 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, Sucralose

TheraBreath Healthy Gums Oral Rinse

label

72551-247-05

72551-247-01

Label

72551-247-04

label

THERABREATH HEALTHY GUMS ORAL RINSE 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72551-247
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.0005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Colorwhite (Clear) Score    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72551-247-01473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2020
2NDC:72551-247-0433.8 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2020
3NDC:72551-247-0588.7 g in 1 POUCH; Type 0: Not a Combination Product12/01/2020
4NDC:72551-247-06958.21 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
5NDC:72551-247-07283.5 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
6NDC:72551-247-0885.05 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
7NDC:72551-247-097.09 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/202001/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/01/2020
Labeler - Dr. Harold Katz, LLC (965507767)

Revised: 2/2022
Document Id: d6f99ac9-02e9-11e5-e053-2a95a90a75f6
Set id: 8f79bf5c-bbab-405a-8438-1fbb7769aec0
Version: 12
Effective Time: 20220201
 
Dr. Harold Katz, LLC