Smartmouth
FDA Label NDC 76357-409

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 (NDC 76357-409). 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, stop use and see your physician promptly if, 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

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

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 - 437 Ml Kit Cello Pack

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 - 296 Ml Kit Cello Pack

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)

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