FDA Label for Smartmouth Advance Clinical Dds Formula Mint
View Indications, Usage & Precautions
Smartmouth Advance Clinical Dds Formula Mint Product Label
The following document was submitted to the FDA by the labeler of this product Triumph Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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)
* Please review the disclaimer below.