FDA Label for Smartmouth Premium Action Smartmouth Advanced Clinical Formula (acf)

View Indications, Usage & Precautions

Smartmouth Premium Action Smartmouth Advanced Clinical Formula (acf) 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.

Other



Drug Facts

Smartmouth® is a trademark
of and distributed by:
Triumph Pharmaceuticals Inc.
St. Louis, Missouri 63114


Active Ingredient



Sodium monofluorophosphate (0.81%) (0.10% w/v of fluoride ion)


Purpose



Anticavity


Use



Aids in the prevention of dental cavities.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients



Sorbitol, Hydrated Silica, Glycerin, Water, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Xanthan Gum, Sodium Benzoate, Benzoic Acid, Sodium Saccharin, Zinc Chloride, D&C Yellow #10 and FD&C Blue #1


Questions Or Comments



1-800-492-7040


Principal Display Panel - 96.4 G Tube Label



smart
mouth™

PREMIUM
TOOTHPASTE

Clinically Developed By Dentists

Zn+2
Protect
Repair
Clean

MILD FLAVOR / NO AFTERTASTE

ANTI-CAVITY WITH FLUORIDE

REMOVES DENTAL PLAQUE

REMINERALIZES ENAMEL

SENSITIVE WHITENING

GUARANTEED

MILD MINT • NET WT. 3.4 OZ (96.4g)


* Please review the disclaimer below.