Smartmouth Advance Clinical Dds Formula Mint
FDA Label NDC 76357-230

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 Advance Clinical Dds Formula Mint (NDC 76357-230). 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, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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DRUG FACTS

SMARTMOUTH™ IS A TRADEMARK
OF AND 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

  • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse (one sample packet) 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.

Other Information

  • This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid

Solution 2: Purified Water, Glycerin, Poloxamer 407, Propylene Glycol, 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 Or Comments

1-800-492-7040

Principal Display Panel - Kit Pouch

H2S ELIMINATOR∞ & Zn+2 ACTIVATOR

smart
mouth™
OTC

Activates Zinc Ions
Blocks Sulfur Gas

Clinical DDS™
ACTIVATED ORAL RINSE™

PRESCRIPTION STRENGTH+
Gingivitis & Bleeding Gums Protection

24HR BAD BREATH
PREVENTION*

AM RINSE = ALL DAY CLEAN BREATH
PM RINSE = ELIMINATES MORNING BREATH

GUARANTEED†

PATENTED FORMULA • DENTIST DEVELOPED
CLEAN MINT • NO AFTERTASTE • ALCOHOL FREE • SAFE FOR DIABETICS • 0.68 FL. OZ. (20 mL)

Principal Display Panel (Kit Pouch)

Principal Display Panel (Kit Pouch)

* Please review the disclaimer below.