Label: SMARTMOUTH ADVANCE CLINICAL DDS FORMULA MINT- cetylpyridinium chloride kit

  • NDC Code(s): 76357-230-01
  • Packager: Triumph Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 5, 2023

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Cetylpyridinium Chloride 0.05% (when mixed as directed)

  • Purpose

    Anti-gingivitis/Anti-plaque

  • Uses

    Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

  • Warnings

    Ask a dentist if symptoms persist or condition worsens after regular use.

    Keep out of reach of children under 6 years of age.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse (one sample packet) twice a day for 30 seconds and then spit out. Do not swallow.
    • Children 6 years to under 12 years of age: supervise use.
    • Children under 6 years of age: do not use.
  • Other information

    • This rinse is not intended to replace brushing or flossing.

    Inactive Ingredients

    Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid

    Solution 2: Purified Water, Glycerin, Poloxamer 407, Propylene Glycol, Poloxamer 124, Zinc Chloride, Flavor, Sodium Benzoate, Benzoic Acid, Sodium Saccharin, Sodium Chloride, Benzyl Alcohol, D&C Yellow No. 10, FD&C Blue No. 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 63141

  • PRINCIPAL DISPLAY PANEL - Kit Pouch

    MIXES TO ACTIVATE
    2 Powerful Solutions

    smart
    mouth™

    Clinical
    Zinc Activated Oral Rinse™

    24
    HOUR

    BAD BREATH
    PREVENTION
    WITH A MORNING & EVENING RINSE

    Prescription Strength Formula+

    Gingivitis & Bleeding Gums Protection

    Dentist Recommended

    Zinc Promotes Oral Health & Boosts Immunity

    CLEAN MINT • 0.68 FL. OZ. [20 mL] • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

    PRINCIPAL DISPLAY PANEL - Kit Pouch
  • INGREDIENTS AND APPEARANCE
    SMARTMOUTH ADVANCE CLINICAL DDS FORMULA MINT 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-230
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76357-230-011 in 1 POUCH12/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 POUCH 10 mL
    Part 21 POUCH 10 mL
    Part 1 of 2
    SMARTMOUTH MOUTHWASH ADVANCE CLINICAL DDS FORMULA SOLUTION 1 (H2S ELIMINATOR) 
    mouthwashes and breath fresheners (liquids and sprays) liquid
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRwater (UNII: 059QF0KO0R)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
    INGRSodium Chlorite (UNII: G538EBV4VF)  
    Product Characteristics
    colorWHITEC48325
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic12/01/2019
    Part 2 of 2
    SMARTMOUTH MOUTHWASH ADVANCE CLINICAL DDS FORMULA SOLUTION 2 (ZN PLUS 2 ACTIVATOR) 
    cetylpyridinium chloride liquid
    Product Information
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE500 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Glycerin (UNII: PDC6A3C0OX)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Poloxamer 124 (UNII: 1S66E28KXA)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Sodium (UNII: 9NEZ333N27)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINT (mint vanilla) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/01/2019
    Labeler - Triumph Pharmaceuticals, Inc. (017853461)
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