SmartMouth

Manufacturer
Triumph Pharmaceuticals Inc.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:05:48

Label at a glance#

ProductSmartMouth Mouth Sore Zinc Activated Formula
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure13 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 should be supervised in the use of this product. Children under 6 years of age: do not use.

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

Stop use and see your physician promptly if

OTC - STOP USE SECTION

  • 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 should be supervised in the use of this product.
  • Children under 6 years of age: do not use.

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 - 437 mL Kit Cello Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Mouth Sore
Zinc Activated Oral Rinse™

24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Soothes Oral Pain & Irritation

For all Mouth Sores, Canker Sores and Cheek Bites

Relieves Gum, Braces and Denture Irritation

Zinc Promotes Oral Health & Boosts Immunity

COOL MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

PRINCIPAL DISPLAY PANEL - 437 mL Kit Cello Pack
PRINCIPAL DISPLAY PANEL - 437 mL Kit Cello Pack

PRINCIPAL DISPLAY PANEL - 437 mL Kit Cello Pack - Breath Rinse

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Mouth Sore
Zinc Activated Breath Rinse™

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 - 437 mL Kit Cello Pack - Breath Rinse
PRINCIPAL DISPLAY PANEL - 437 mL Kit Cello Pack - Breath Rinse

PRINCIPAL DISPLAY PANEL - 296 mL Kit Cello Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Mouth Sore
Zinc Activated Oral Rinse™

24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Soothes Oral Pain & Irritation

For all Mouth Sores, Canker Sores and Cheek Bites

Relieves Gum, Braces and Denture Irritation

Zinc Promotes Oral Health & Boosts Immunity

COOL MINT • 10 FL. OZ. (296 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

PRINCIPAL DISPLAY PANEL - 296 mL Kit Cello Pack
PRINCIPAL DISPLAY PANEL - 296 mL Kit Cello Pack

PRINCIPAL DISPLAY PANEL - 320 mL Kit Cello Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Mouth Sore
Zinc Activated Oral Rinse™

24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Soothes Oral Pain & Irritation

For all Mouth Sores, Canker Sores and Cheek Bites

Relieves Gum, Braces and Denture Irritation

Zinc Promotes Oral Health & Boosts Immunity

COOL MINT • 10.82 FL. OZ. (320 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

PRINCIPAL DISPLAY PANEL - 320 mL Kit Cello Pack
PRINCIPAL DISPLAY PANEL - 320 mL Kit Cello Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2108024menthol 0.2 % MouthwashPSN4
2108024menthol 2 MG/ML MouthwashSCD4
2108024menthol 0.2 % MouthwashSY4

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-409-16SmartMouth Mouth Sore Zinc Activated Formula1 in 1 CELLO PACKKIT14
76357-410-01SmartMouth Mouth Sore Zinc Activated Formula1 in 1 CELLO PACKKIT14
76357-411-10SmartMouth Mouth Sore Zinc Activated Formula1 in 1 CELLO PACKKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-409SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA (MENTHOL, UNSPECIFIED FORM) KIT [TRIUMPH PHARMACEUTICALS INC.]4Legacy NDC, 1 package rows20231228_6b5bea76-89a0-42db-aa7f-5a3c1dffda1c.zip
76357-410SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA (MENTHOL, UNSPECIFIED FORM) KIT [TRIUMPH PHARMACEUTICALS INC.]4Legacy NDC, 1 package rows20231228_6b5bea76-89a0-42db-aa7f-5a3c1dffda1c.zip
76357-411SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA (MENTHOL, UNSPECIFIED FORM) KIT [TRIUMPH PHARMACEUTICALS INC.]4Legacy NDC, 1 package rows20231228_6b5bea76-89a0-42db-aa7f-5a3c1dffda1c.zip

Products#

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

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NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 63 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
1459a9d3-0005-4d84-ad38-67465672feb96b5bea76-89a0-42db-aa7f-5a3c1dffda1c2023-12-21WarningsExact identifier
spl id: 1459a9d3-0005-4d84-ad38-67465672feb9
spl set id: 6b5bea76-89a0-42db-aa7f-5a3c1dffda1c

Reported adverse events (FAERS/openFDA)#

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