SmartMouth™ Mouthwash Mouth Sore Solution 1

Manufacturer
Triumph Pharmaceuticals, Inc.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:50:17

Label at a glance#

ProductSmartMouth Mouthwash SmartMouth Mouth Sore Zinc Activated Formula
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

For the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat. For the temporary relief of pain associated with: Canker sores Minor dental procedures Minor irritation or injury of the mouth or gums Minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Dosage and administration

Adults and children 12 years of age & older: Swish 20mL of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children 6 years to under 12 years of age: supervise use. Children under 6 years of age: do not use unless directed by a healthcare professional.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.2% (when mixed as directed)

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat. For the temporary relief of pain associated with:

  • Canker sores
  • Minor dental procedures
  • Minor irritation or injury of the mouth or gums
  • Minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use this product for more than 7 days unless directed by a dentist or healthcare provider

OTC - WHEN USING SECTION

When using this product do not swallow

  • do not exceed recommended dosage

OTC - STOP USE SECTION

Stop use and see your physician promptly if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 & older: Swish 20mL of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.
  • Children 6 years to under 12 years of age: supervise use.
  • Children under 6 years of age: do not use unless directed by a healthcare professional.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-492-7040

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC.
ST. LOUIS, MISSOURI 63141

PRINCIPAL DISPLAY PANEL - Kit Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW &
IMPROVED
POUR

MIXES TO
ACTIVATE
2 Powerful Solutions

BLOCKS
ODORS

FRESHENS
BREATH

smart
mouth™

Mouth Sore

Scientifically Proven
Smart-Zinc™ Technology

24
HOUR

BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Oral Pain Relief For

CANKER SORES & CHEEK BITES

GUM, BRACES & DENTURE IRRITATION

COOL MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE

PRINCIPAL DISPLAY PANEL - Kit Bottle Label
PRINCIPAL DISPLAY PANEL - Kit Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2108024menthol 0.2 % MouthwashPSN1
2108024menthol 2 MG/ML MouthwashSCD1
2108024menthol 0.2 % MouthwashSY1

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
76357-419-002026-01-29C16284748780-149896155-aa62-586f-e063-e6dba90add90SmartMouth™ Mouthwash Mouth Sore Solution 1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-419-00SmartMouth Mouthwash SmartMouth Mouth Sore Zinc Activated Formula1 in 1 CARTONKIT11
76357-489-02SmartMouth Mouthwash SmartMouth Mouth Sore Zinc Activated Formula237 mL in 1 BOTTLELIQUID237 mL10 mg in 20mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-419SMARTMOUTH MOUTHWASH SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA (MENTHOL, UNSPECIFIED FORM) KIT [TRIUMPH PHARMACEUTICALS, INC.]12 package rows20250101_f1e5f1e0-ad3f-4bc6-a2ca-5ec71f081815.zip
76357-489SMARTMOUTH MOUTHWASH SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA (MENTHOL, UNSPECIFIED FORM) KIT [TRIUMPH PHARMACEUTICALS, INC.]1Unmatched20250101_f1e5f1e0-ad3f-4bc6-a2ca-5ec71f081815.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76357-41976357-419-00
76357-48976357-489-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
398e485a-64c5-4d1e-81f0-9d50a17421d6f1e5f1e0-ad3f-4bc6-a2ca-5ec71f0818152024-12-18WarningsExact identifier
spl id: 398e485a-64c5-4d1e-81f0-9d50a17421d6
spl set id: f1e5f1e0-ad3f-4bc6-a2ca-5ec71f081815

Reported adverse events (FAERS/openFDA)#

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