Label: SMARTMOUTH ADVANCE CLINICAL FORMULA- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 12, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    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)

    Principal Display Panel - 170 g Tube Label
  • INGREDIENTS AND APPEARANCE
    SMARTMOUTH   ADVANCE CLINICAL FORMULA
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-106
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1 mg  in 1 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)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINT (mint vanilla) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76357-106-04170 g in 1 TUBE; Type 0: Not a Combination Product06/17/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35506/17/2011
    Labeler - Triumph Pharmaceuticals Inc. (017853461)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!