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SmartMouth

Triumph Pharmaceuticals Inc.

Smart Mouth™ ADVANCED CLINICAL FORMULA™ TOOTHPASTE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

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

Purpose

Anticavity

Use

  • Aids in the prevention of dental cavities.

Warnings

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

SmartMouth™ is a trademark of
and distributed by:
Triumph
Pharmaceuticals Inc.

St. Louis, Missouri 63132
Made in USA ©2011

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

ADVANCED
CLINICAL FORMULA™
TOOTHPASTE

Smart
Mouth

"FRESH
FROM THE
DENTIST"
FEELING

+

FRESHENS BREATH
WITH
SMART-ZINC™

FLUORIDE FORMULA

  • ANTI-CAVITY
  • REMOVES PLAQUE

REFRESHING MINT

NET WT. 6 OZ. (170 g)

SmartMouth

SmartMouth

Sodium Monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76357-106
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION 17 g

Inactive Ingredients

Ingredient Name Strength
sorbitol
HYDRATED SILICA
GLYCERIN
water
SODIUM LAURYL SULFATE
titanium dioxide
XANTHAN GUM
SODIUM BENZOATE
BENZOIC ACID
saccharin sodium
ZINC CHLORIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1

Product Characteristics

Color
GREEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76357-106-04 170 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-06-17


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Be sure to consult your doctor before taking any medication!
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