Label: SMARTMOUTH MOUTHWASH CLINICAL DDS FORMULA- cetylpyridinium chloride kit

  • NDC Code(s): 76357-285-01
  • 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 February 7, 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 (5 pumps from each bottle) 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™ & SMART MOUTH™
    ARE TRADEMARKS OF & DISTRIBUTED BY:
    TRIUMPH PHARMACEUTICALS INC. • ST. LOUIS, MISSOURI 63141

  • PRINCIPAL DISPLAY PANEL - Kit Cello Pack

    H2S ELIMINATOR∞ & Zn+2 ACTIVATOR

    smart
    mouth™
    OTC

    Activates Zinc Ions
    Blocks Sulfur Gas

    Clinical DDS™
    ACTIVATED ORAL RINSE™

    PRESCRIPTION STRENGTH+
    Gingivitis & Bleeding Gums Protection

    24HR
    BAD BREATH
    PREVENTION*

    AM RINSE = ALL DAY CLEAN BREATH
    PM RINSE = ELIMINATES MORNING BREATH

    GUARANTEED†

    PATENTED FORMULA • DENTIST DEVELOPED

    CLEAN MINT • NO AFTERTASTE
    ALCOHOL FREE • SAFE FOR DIABETICS

    TOTAL NET WT.
    32 FL. OZ. (960 mL)

    Principal Display Panel - Kit Cello Pack
  • INGREDIENTS AND APPEARANCE
    SMARTMOUTH MOUTHWASH   CLINICAL DDS FORMULA
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-285
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76357-285-011 in 1 CELLO PACK; Type 0: Not a Combination Product10/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 480 mL
    Part 21 BOTTLE, PLASTIC 480 mL
    Part 1 of 2
    SMARTMOUTH   CLINICAL DDS SOLUTION 1
    mouthwashes and breath fresheners (liquids and sprays)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRSodium Chlorite (UNII: G538EBV4VF)  
    INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
    Product Characteristics
    colorWHITEC48325
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC10/01/2018
    Part 2 of 2
    SMARTMOUTH   CLINICAL DDS SOLUTION 2 MINT
    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)  
    Glycerin (UNII: PDC6A3C0OX)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Poloxamer 124 (UNII: 1S66E28KXA)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    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
    1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35610/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35610/01/2018
    Labeler - Triumph Pharmaceuticals Inc. (017853461)
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