SMARTMOUTH ADVANCE CLINICAL FORMULA- sodium monofluorophosphate paste, dentifrice

SmartMouth by

Drug Labeling and Warnings

SmartMouth by is a Otc medication manufactured, distributed, or labeled by Triumph Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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

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. 6 OZ (170g)

INGREDIENTS AND APPEARANCE

SMARTMOUTH   ADVANCE CLINICAL FORMULA
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76357-106
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Titanium Dioxide (UNII: 15FIX9V2JP)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Benzoate (UNII: OJ245FE5EU)
Benzoic Acid (UNII: 8SKN0B0MIM)
Saccharin Sodium (UNII: SB8ZUX40TY)
Zinc Chloride (UNII: 86Q357L16B)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT (mint vanilla)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76357-106-04	170 g in 1 TUBE; Type 0: Not a Combination Product	06/17/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	06/17/2011

Labeler - Triumph Pharmaceuticals Inc. (017853461)