SMARTMOUTH PREMIUM ACTION SMARTMOUTH ADVANCED CLINICAL FORMULA (ACF)- sodium monofluorophosphate paste, dentifrice 
Triumph Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SmartMouth™ Premium Action Toothpaste
SmartMouth™ Toothpaste Advanced Clinical Formula (ACF)

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

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 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)

Principal Display Panel - 96.4 g Tube Label
SMARTMOUTH PREMIUM ACTION  SMARTMOUTH ADVANCED CLINICAL FORMULA (ACF)
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-175
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion10.21 g  in 96.4 g
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScore    
ShapeSize
FlavorMINT, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76357-175-0096.4 g in 1 TUBE; Type 0: Not a Combination Product02/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2018
Labeler - Triumph Pharmaceuticals Inc. (017853461)

Revised: 2/2023
Document Id: 43940664-f1da-476b-82ab-49a913fe58a6
Set id: 4926e9a5-7f7a-40aa-b782-e731bfa45190
Version: 5
Effective Time: 20230207
 
Triumph Pharmaceuticals Inc.