FDA Label for Smartmouth Smartmouth Gum Health Zinc Activated Formula

View Indications, Usage & Precautions

Smartmouth Smartmouth Gum Health Zinc Activated Formula 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

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


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