Label: SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA- cetylpyridinium chloride kit
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NDC Code(s):
76357-210-01,
76357-211-01,
76357-250-09,
76357-255-01, view more76357-290-01
- Packager: Triumph Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
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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
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - Oral Rinse
MIXES TO ACTIVATE
2 Powerful Solutionssmart
mouth™Clinical
Zinc Activated Oral Rinse™24
HOURBAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSEPrescription 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 - Breath Rinse
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PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
MIXES TO ACTIVATE
2 Powerful Solutionssmart
mouth™Clinical
Zinc Activated Oral Rinse™24
HOURBAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSEPrescription Strength Formula+
Gingivitis & Bleeding Gums Protection
Dentist Recommended
Zinc Promotes Oral Health & Boosts Immunity
CLEAN MINT • 32 FL. OZ. (946 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES
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PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label
MIXES TO ACTIVATE
2 Powerful Solutionssmart
mouth™Clinical
Zinc Activated Oral Rinse™24
HOURBAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSEPrescription 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
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PRINCIPAL DISPLAY PANEL - 320 mL Bottle Label
MIXES TO ACTIVATE
2 Powerful Solutionssmart
mouth™Clinical
Zinc Activated Oral Rinse™24
HOURBAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSEPrescription 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
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INGREDIENTS AND APPEARANCE
SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76357-250 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-250-09 1 in 1 CELLO PACK 09/28/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 236.5 mL Part 2 1 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 Administration DENTAL Other Ingredients Ingredient Kind Ingredient Name Quantity COLR White () INGR Water (UNII: 059QF0KO0R) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Sodium Chlorite (UNII: G538EBV4VF) INGR Benzoic Acid (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 236.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 09/28/2015 Part 2 of 2 SMARTMOUTH GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquidProduct Information Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium Chloride 500 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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 Color GREEN Score Shape Size Flavor MINT (mint vanilla) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 236.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 09/28/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 09/28/2015 SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76357-255 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-255-01 1 in 1 CELLO PACK 02/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 473 mL Part 2 1 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 Administration DENTAL Other Ingredients Ingredient Kind Ingredient Name Quantity COLR White () INGR Water (UNII: 059QF0KO0R) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Sodium Chlorite (UNII: G538EBV4VF) INGR Benzoic Acid (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 02/01/2018 Part 2 of 2 SMARTMOUTH GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquidProduct Information Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium Chloride 500 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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 Color GREEN Score Shape Size Flavor MINT (mint vanilla) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 02/01/2018 SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76357-210 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-210-01 1 in 1 CELLO PACK 12/02/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 296 mL Part 2 1 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 Administration DENTAL Other Ingredients Ingredient Kind Ingredient Name Quantity COLR White () INGR Water (UNII: 059QF0KO0R) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Sodium Chlorite (UNII: G538EBV4VF) INGR Benzoic Acid (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 12/02/2020 Part 2 of 2 SMARTMOUTH GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquidProduct Information Item Code (Source) NDC:76357-290 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium Chloride 500 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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 Color GREEN Score Shape Size Flavor MINT (mint vanilla) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-290-01 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 12/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 12/02/2020 SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76357-211 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-211-01 1 in 1 CELLO PACK 01/01/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 160 mL Part 2 1 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 Administration DENTAL Other Ingredients Ingredient Kind Ingredient Name Quantity COLR White () INGR Water (UNII: 059QF0KO0R) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Sodium Chlorite (UNII: G538EBV4VF) INGR Benzoic Acid (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2023 Part 2 of 2 SMARTMOUTH GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquidProduct Information Item Code (Source) NDC:76357-291 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium Chloride 500 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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 Color GREEN Score Shape Size Flavor MINT (mint vanilla) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 01/01/2023 Labeler - Triumph Pharmaceuticals Inc. (017853461)
