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DRUG FACTS
DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC.
ST. LOUIS, MISSOURI 63114
Smartmouth
FDA Label NDC 76357-255
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 76357-255). 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.
Label Section Quick Index
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 (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.
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 - 473 Ml Bottle Label
Both Liquids with a Single Pour
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
24 HR
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 • 16 FL. OZ. (473 mL)
Principal Display Panel (473 mL Bottle Label)
Principal Display Panel - 946 Ml Bottle Label
Both Liquids with a Single Pour
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
24 HR
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 • 32 FL. OZ. (946 mL)
Principal Display Panel (946 mL Bottle Label)
* Please review the disclaimer below.
