Smartmouth
FDA Label NDC 76357-509

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 76357-509). 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 - ask doctor, otc - keep out of reach of children, directions, inactive ingredients, 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

Cetylpyridinium Chloride 0.05% (when mixed as directed)

Purpose

Anti-gingivitis/Anti-plaque

Uses

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

Otc - Ask Doctor

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

Otc - Keep Out Of Reach Of Children

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

  • Use after your normal brushing and flossing routine
  • Adults and children 12 years of age & older: vigorously swish 20 mL of rinse (pour to indicator line on cap) 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 unless directed by a healthcare professional.

Inactive Ingredients

Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid. Solution 2: Purified Water, Glycerin, Poloxamer 407, Propylene Glycol, Aloe Vera, 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?

1-800-492-7040

Principal Display Panel - Kit Label

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Gum Health
Zinc Activated Breath Rinse™

24
HOUR

BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Advanced Germ Killing+
BLEEDING GUMS PROTECTION
SOOTHES WITH NATURAL ALOE

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

Principal Display Panel (Kit Label)

Principal Display Panel (Kit Label)

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