Label: SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA- cetylpyridinium chloride kit

  • NDC Code(s): 76357-509-01, 76357-599-02
  • Packager: Triumph Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 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

    • Use after your normal brushing and flossing routine
    • Adults and children 12 years of age & older: vigorously swish 20 mL of rinse (pour to indicator line on cap) 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 unless directed by a healthcare professional.
  • Inactive Ingredients

    Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid. Solution 2: Purified Water, Glycerin, Poloxamer 407, Propylene Glycol, Aloe Vera, 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?

    1-800-492-7040

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    TRIUMPH PHARMACEUTICALS INC.
    ST. LOUIS, MISSOURI 63141

  • PRINCIPAL DISPLAY PANEL - Kit Label

    MIXES TO ACTIVATE
    2 Powerful Solutions

    smart
    mouth™

    Gum Health
    Zinc Activated Breath Rinse™

    24
    HOUR

    BAD BREATH
    PREVENTION
    WITH A MORNING & EVENING RINSE

    Advanced Germ Killing+
    BLEEDING GUMS PROTECTION
    SOOTHES WITH NATURAL ALOE

    MILD MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE

    PRINCIPAL DISPLAY PANEL - Kit Label
  • INGREDIENTS AND APPEARANCE
    SMARTMOUTH   SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-509
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76357-509-011 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 237 mL
    Part 21 BOTTLE 237 mL
    Part 1 of 2
    SMARTMOUTH   GUM HEALTH SOLUTION 1
    mouthwashes and breath fresheners (liquids and sprays) [oral products] liquid
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRSodium Chlorite (UNII: G538EBV4VF)  
    INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC01/01/2024
    Part 2 of 2
    SMARTMOUTH   GUM HEALTH SOLUTION 2
    cetylpyridinium chloride liquid
    Product Information
    Item Code (Source)NDC:76357-599
    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)  
    ALOE (UNII: V5VD430YW9)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    Zinc Chloride (UNII: 86Q357L16B)  
    SODIUM (UNII: 9NEZ333N27)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINT (Mild Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76357-599-02237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/01/2024
    Labeler - Triumph Pharmaceuticals, Inc. (017853461)
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