FDA.reportPublic FDA data

TheraBreath Healthy Gums Oral Rinse

Manufacturer
Dr. Harold Katz, LLC
Effective date
2022-02-01
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-05-31 23:47:56

Label at a glance#

ProductTheraBreath Healthy Gums Oral Rinse
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure11 sections

Indications and uses

•Helps prevent gingivitis, an early form of gum disease and bleeding gum •Helps control plaque that leads to gingivitis and 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 under12 years supervise use. Children under 6 years Do not use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.05%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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.

Warnings

WARNINGS SECTION

Stop Use and Ask a Doctor 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 or symptoms of periodontitis, a serious form of gum disease.

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 under12 yearssupervise use.
Children under 6 yearsDo not use.

Other Information

OTHER SAFETY INFORMATION

This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Poloxamer 407, Flavor, Sucralose

TheraBreath Healthy Gums Oral Rinse

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

72551-247-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72551-247-01

LabelLabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72551-247-04

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72551-247-012024-01-30C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-042024-01-30C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-052024-01-30C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-062024-01-30C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-072024-01-30C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-082024-01-30C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-092024-01-30C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-012021-02-10C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-022021-02-10C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-032021-02-10C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-012021-01-29C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-022021-01-29C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse
72551-247-032021-01-29C16284748780-1ba0f9c33-1ba4-a910-e053-dadaa90a0b85TheraBreath Healthy Gums Oral Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72551-247-01TheraBreath Healthy Gums Oral Rinse473 g in 1 BOTTLE, PLASTICRINSE47312
72551-247-04TheraBreath Healthy Gums Oral Rinse33.8 g in 1 BOTTLE, PLASTICRINSE33.812
72551-247-05TheraBreath Healthy Gums Oral Rinse88.7 g in 1 POUCHRINSE88.712
72551-247-06TheraBreath Healthy Gums Oral Rinse958.21 g in 1 BOTTLERINSE958.2112
72551-247-07TheraBreath Healthy Gums Oral Rinse283.5 g in 1 BOTTLERINSE283.512
72551-247-08TheraBreath Healthy Gums Oral Rinse85.05 g in 1 BOTTLERINSE85.0512
72551-247-09TheraBreath Healthy Gums Oral Rinse7.09 g in 1 BOTTLERINSE7.0912

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72551-247THERABREATH HEALTHY GUMS ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) RINSE [DR. HAROLD KATZ, LLC]12Legacy NDC, 7 package rows20220204_8f79bf5c-bbab-405a-8438-1fbb7769aec0.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72551-24772551-247-01, 72551-247-04, 72551-247-05, 72551-247-06, 72551-247-07, 72551-247-08, 72551-247-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
GLYCERINPDC6A3C0OXIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d6f99ac9-02e9-11e5-e053-2a95a90a75f68f79bf5c-bbab-405a-8438-1fbb7769aec02022-02-01WarningsExact identifier
spl id: d6f99ac9-02e9-11e5-e053-2a95a90a75f6
spl set id: 8f79bf5c-bbab-405a-8438-1fbb7769aec0

Reported adverse events (FAERS/openFDA)#

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