FDA.reportPublic FDA data

SmartMouth Mouthwash

Manufacturer
Triumph Pharmaceuticals Inc.
Effective date
2023-02-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:53:45

Label at a glance#

ProductSmartMouth Mouthwash Clinical DDS Formula
Active ingredientCetylpyridinium Chloride
Label structure11 sections

Indications and uses

Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Dosage and administration

Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse (5 pumps from each bottle) twice a day for 30 seconds and then spit out. Do not swallow. Children 6 years to under 12 years of age: supervise use. Children under 6 years of age: 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 0.05% (when mixed as directed)

Purpose

OTC - PURPOSE SECTION

Anti-gingivitis/Anti-plaque

Uses

INDICATIONS & USAGE SECTION

Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Warnings

WARNINGS SECTION

Ask a dentist if symptoms persist or condition worsens after regular use.

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 of age and older: vigorously swish 20 milliliters of rinse (5 pumps from each bottle) twice a day for 30 seconds and then spit out. Do not swallow.
  • Children 6 years to under 12 years of age: supervise use.
  • Children under 6 years of age: do not use.

Other information

STORAGE AND HANDLING SECTION

  • This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid

Solution 2: Purified Water, Glycerin, Poloxamer 407, Propylene Glycol, Poloxamer 124, Zinc Chloride, Flavor, Sodium Benzoate, Benzoic Acid, Sodium Saccharin, Sodium Chloride, Benzyl Alcohol, D&C Yellow No. 10, FD&C Blue No. 1

Questions or comments

OTC - QUESTIONS SECTION

1-800-492-7040

SPL UNCLASSIFIED SECTION

SMARTMOUTH™ & SMART MOUTH™
ARE TRADEMARKS OF & DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC. • ST. LOUIS, MISSOURI 63141

PRINCIPAL DISPLAY PANEL - Kit Cello Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H2S ELIMINATOR∞ & Zn+2 ACTIVATOR

smart
mouth™
OTC

Activates Zinc Ions
Blocks Sulfur Gas

Clinical DDS™
ACTIVATED ORAL RINSE™

PRESCRIPTION STRENGTH+
Gingivitis & Bleeding Gums Protection

24HR
BAD BREATH
PREVENTION*

AM RINSE = ALL DAY CLEAN BREATH
PM RINSE = ELIMINATES MORNING BREATH

GUARANTEED†

PATENTED FORMULA • DENTIST DEVELOPED

CLEAN MINT • NO AFTERTASTE
ALCOHOL FREE • SAFE FOR DIABETICS

TOTAL NET WT.
32 FL. OZ. (960 mL)

Principal Display Panel - Kit Cello Pack
Principal Display Panel - Kit Cello Pack

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76357-285-012025-01-30C16284748780-1f386c64a-332b-0266-e053-dadaa90a7c1aSmartMouth™ Mouthwash Clinical DDS™ Formula
76357-285-012024-01-30C16284748780-1f386c64a-332b-0266-e053-dadaa90a7c1aSmartMouth™ Mouthwash Clinical DDS™ Formula
76357-285-012023-02-07C16284748780-1f386c64a-332b-0266-e053-dadaa90a7c1aSmartMouth™ Mouthwash Clinical DDS™ Formula
76357-285-012023-01-30C16284748780-1f386c64a-332b-0266-e053-dadaa90a7c1aSmartMouth™ Mouthwash Clinical DDS™ Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-285-01SmartMouth Mouthwash Clinical DDS Formula1 in 1 CELLO PACKKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-285SMARTMOUTH MOUTHWASH CLINICAL DDS FORMULA (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS INC.]5Legacy NDC, 1 package rows20230208_87057ce9-e3b2-44f5-bac0-951aeecad768.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76357-28576357-285-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
Water059QF0KO0RINGR
Sodium BenzoateOJ245FE5EUINGR
Sodium ChloriteG538EBV4VFINGR
Benzoic Acid8SKN0B0MIMINGR
Cetylpyridinium ChlorideD9OM4SK49PACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Poloxamer 407TUF2IVW3M2IACT
Propylene Glycol6DC9Q167V3IACT
Poloxamer 1241S66E28KXAIACT
Zinc Chloride86Q357L16BIACT
Sodium BenzoateOJ245FE5EUIACT
Benzoic Acid8SKN0B0MIMIACT
Saccharin SodiumSB8ZUX40TYIACT
Sodium Chloride451W47IQ8XIACT
Benzyl AlcoholLKG8494WBHIACT
D&C Yellow No. 1035SW5USQ3GIACT
FD&C Blue No. 1H3R47K3TBDIACT

Source Document#

Source XML · Source PDF

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
d9300784-e2ae-423c-9f58-152259b1fc9987057ce9-e3b2-44f5-bac0-951aeecad7682023-02-07WarningsExact identifier
spl id: d9300784-e2ae-423c-9f58-152259b1fc99
spl set id: 87057ce9-e3b2-44f5-bac0-951aeecad768

Reported adverse events (FAERS/openFDA)#

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