Smartmouth Mouthwash
FDA Label NDC 76357-419

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Triumph Pharmaceuticals, Inc. for the product Smartmouth Mouthwash (NDC 76357-419). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredient

Menthol 0.2% (when mixed as directed)

Purpose

Oral Pain Reliever

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

Otc - Do Not Use

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

Otc - When Using

When using this product do not swallow

  • do not exceed recommended dosage

Otc - Stop Use

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

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

  • 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

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?

1-800-492-7040

Principal Display Panel - Kit Bottle Label

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)

* Please review the disclaimer below.