Label: SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA- cetylpyridinium chloride kit

  • NDC Code(s): 76357-210-01, 76357-211-01, 76357-250-09, 76357-255-01, view more
    76357-290-01
  • Packager: Triumph Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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

  • 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 (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.
  • 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

    DISTRIBUTED BY:
    TRIUMPH PHARMACEUTICALS INC.
    ST. LOUIS, MISSOURI 63114

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - Oral Rinse

    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 • 16 FL. OZ. (473 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - Oral Rinse
  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - Breath Rinse

    NEW &
    IMPROVED
    POUR

    MIXES TO
    ACTIVATE
    2 Powerful Solutions

    BLOCKS
    ODORS

    FRESHENS
    BREATH

    smart
    mouth™

    Clinical
    Scientifically Proven
    Smart-Zinc™ Technology

    24
    HOUR

    BAD BREATH
    PREVENTION
    WITH A MORNING & EVENING RINSE

    Prescription Strength+

    ANTI-PLAQUE

    ANTI-GINGIVITIS

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

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - Breath Rinse
  • PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

    NEW &
    IMPROVED
    POUR

    MIXES TO
    ACTIVATE
    2 Powerful Solutions

    BLOCKS
    ODORS

    FRESHENS
    BREATH

    smart
    mouth™

    Clinical
    Scientifically Proven
    Smart-Zinc™ Technology

    24
    HOUR

    BAD BREATH
    PREVENTION
    WITH A MORNING & EVENING RINSE

    Prescription Strength+

    ANTI-PLAQUE

    ANTI-GINGIVITIS

    CLEAN MINT • 32 FL. OZ. (946 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

    PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label

    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 • 10 FL. OZ. (296 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

    PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 320 mL Bottle Label

    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 • 10.82 FL. OZ. (320 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES

    PRINCIPAL DISPLAY PANEL - 320 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SMARTMOUTH   CLINICAL GUM AND PLAQUE FORMULA
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-250
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76357-250-091 in 1 CELLO PACK09/28/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 236.5 mL
    Part 21 BOTTLE, PLASTIC 236.5 mL
    Part 1 of 2
    SMARTMOUTH   GUM AND PLAQUE SOLUTION 1
    mouthwashes and breath fresheners (liquids and sprays) [oral products]
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    COLRWhite ()  
    INGRWater (UNII: 059QF0KO0R)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRSodium Chlorite (UNII: G538EBV4VF)  
    INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1236.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic09/28/2015
    Part 2 of 2
    SMARTMOUTH   GUM AND PLAQUE 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
    1236.5 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 DrugM02209/28/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02209/28/2015
    SMARTMOUTH   CLINICAL GUM AND PLAQUE FORMULA
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-255
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76357-255-011 in 1 CELLO PACK02/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 473 mL
    Part 21 BOTTLE, PLASTIC 473 mL
    Part 1 of 2
    SMARTMOUTH   GUM AND PLAQUE SOLUTION 1
    mouthwashes and breath fresheners (liquids and sprays) [oral products]
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    COLRWhite ()  
    INGRWater (UNII: 059QF0KO0R)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRSodium Chlorite (UNII: G538EBV4VF)  
    INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic02/01/2018
    Part 2 of 2
    SMARTMOUTH   GUM AND PLAQUE 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
    1473 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 DrugM02202/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02202/01/2018
    SMARTMOUTH   CLINICAL GUM AND PLAQUE FORMULA
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-210
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76357-210-011 in 1 CELLO PACK12/02/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 296 mL
    Part 21 BOTTLE, PLASTIC 296 mL
    Part 1 of 2
    SMARTMOUTH   GUM AND PLAQUE SOLUTION 1
    mouthwashes and breath fresheners (liquids and sprays) [oral products]
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    COLRWhite ()  
    INGRWater (UNII: 059QF0KO0R)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRSodium Chlorite (UNII: G538EBV4VF)  
    INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic12/02/2020
    Part 2 of 2
    SMARTMOUTH   GUM AND PLAQUE SOLUTION 2 MINT
    cetylpyridinium chloride liquid
    Product Information
    Item Code (Source)NDC:76357-290
    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
    1NDC:76357-290-01296 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 DrugM02212/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/02/2020
    SMARTMOUTH   CLINICAL GUM AND PLAQUE FORMULA
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-211
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76357-211-011 in 1 CELLO PACK01/01/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 160 mL
    Part 21 BOTTLE, PLASTIC 160 mL
    Part 1 of 2
    SMARTMOUTH   GUM AND PLAQUE SOLUTION 1
    mouthwashes and breath fresheners (liquids and sprays) [oral products]
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    COLRWhite ()  
    INGRWater (UNII: 059QF0KO0R)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRSodium Chlorite (UNII: G538EBV4VF)  
    INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/2023
    Part 2 of 2
    SMARTMOUTH   GUM AND PLAQUE SOLUTION 2 MINT
    cetylpyridinium chloride liquid
    Product Information
    Item Code (Source)NDC:76357-291
    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
    1160 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 DrugM02201/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/01/2023
    Labeler - Triumph Pharmaceuticals Inc. (017853461)