SMARTMOUTH PREMIUM ACTION SMARTMOUTH ADVANCED CLINICAL FORMULA (ACF)- sodium monofluorophosphate paste, dentifrice

SmartMouth Premium Action by

Drug Labeling and Warnings

SmartMouth Premium Action 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 63114

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)

INGREDIENTS AND APPEARANCE

SMARTMOUTH PREMIUM ACTION  SMARTMOUTH ADVANCED CLINICAL FORMULA (ACF)
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76357-175
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	10.21 g  in 96.4 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)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT, VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76357-175-00	96.4 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/01/2018

Labeler - Triumph Pharmaceuticals Inc. (017853461)