Label: SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA- menthol, unspecified form kit
- NDC Code(s): 76357-409-16, 76357-410-01, 76357-411-10
- 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
For the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.
For the temporary relief of pain associated with:
- Canker sores
- Minor dental procedures
- Minor irritation or injury of the mouth or gums
- Minor irritation of the mouth and gums caused by dentures or orthodontic appliances
- Warnings
-
Directions
- Adults and children 12 years of age & older: Swish 20mL of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.
- Children 6 years to under 12 years of age should be supervised in the use of this product.
- Children under 6 years of age: do not use.
-
Inactive Ingredients
Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid. Solution 2: Purified Water, Sorbitol, Poloxamer 407, Glycerin, Propylene Glycol, Poloxamer 124, Zinc Chloride, Flavor, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Peppermint Oil, Benzoic Acid, Aloe Extract, Sodium Chloride, D&C Yellow No. 10, FD&C Blue No. 1
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 437 mL Kit Cello Pack
MIXES TO ACTIVATE
2 Powerful Solutionssmart
mouth™Mouth Sore
Zinc Activated Oral Rinse™24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSESoothes Oral Pain & Irritation
For all Mouth Sores, Canker Sores and Cheek Bites
Relieves Gum, Braces and Denture Irritation
Zinc Promotes Oral Health & Boosts Immunity
COOL MINT • 16 FL. OZ. (473 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES
- PRINCIPAL DISPLAY PANEL - 437 mL Kit Cello Pack - Breath Rinse
-
PRINCIPAL DISPLAY PANEL - 296 mL Kit Cello Pack
MIXES TO ACTIVATE
2 Powerful Solutionssmart
mouth™Mouth Sore
Zinc Activated Oral Rinse™24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSESoothes Oral Pain & Irritation
For all Mouth Sores, Canker Sores and Cheek Bites
Relieves Gum, Braces and Denture Irritation
Zinc Promotes Oral Health & Boosts Immunity
COOL MINT • 10 FL. OZ. (296 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES
-
PRINCIPAL DISPLAY PANEL - 320 mL Kit Cello Pack
MIXES TO ACTIVATE
2 Powerful Solutionssmart
mouth™Mouth Sore
Zinc Activated Oral Rinse™24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSESoothes Oral Pain & Irritation
For all Mouth Sores, Canker Sores and Cheek Bites
Relieves Gum, Braces and Denture Irritation
Zinc Promotes Oral Health & Boosts Immunity
COOL MINT • 10.82 FL. OZ. (320 mL) • ALCOHOL FREE • SAFE FOR PEOPLE WITH DIABETES
-
INGREDIENTS AND APPEARANCE
SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA
menthol, unspecified form kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76357-409 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-409-16 1 in 1 CELLO PACK 01/01/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 237 mL Part 2 1 BOTTLE, PLASTIC 237 mL Part 1 of 2 SMARTMOUTH MOUTH SORE SOLUTION 1
mouthwashes and breath fresheners (liquids and sprays) [oral products] liquidProduct Information Route of Administration DENTAL Other Ingredients Ingredient Kind Ingredient Name Quantity COLR White () INGR Water (UNII: 059QF0KO0R) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Benzoic Acid (UNII: 8SKN0B0MIM) INGR Sodium Chlorite (UNII: G538EBV4VF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 237 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 01/01/2022 Part 2 of 2 SMARTMOUTH MOUTH SORE SOLUTION 2
menthol, unspecified form liquidProduct Information Item Code (Source) NDC:76357-499 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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) Sorbitol (UNII: 506T60A25R) Aloe Vera Leaf (UNII: ZY81Z83H0X) Peppermint Oil (UNII: AV092KU4JH) Product Characteristics Color GREEN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 237 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 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M022 01/01/2022 SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA
menthol, unspecified form kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76357-411 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-411-10 1 in 1 CELLO PACK 01/01/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 138 mL Part 2 1 BOTTLE, PLASTIC 138 mL Part 1 of 2 SMARTMOUTH MOUTH SORE SOLUTION 1
mouthwashes and breath fresheners (liquids and sprays) [oral products] liquidProduct Information Route of Administration DENTAL Other Ingredients Ingredient Kind Ingredient Name Quantity COLR White () INGR Water (UNII: 059QF0KO0R) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Benzoic Acid (UNII: 8SKN0B0MIM) INGR Sodium Chlorite (UNII: G538EBV4VF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 138 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 01/01/2022 Part 2 of 2 SMARTMOUTH MOUTH SORE SOLUTION 2
menthol, unspecified form liquidProduct Information Item Code (Source) NDC:76357-491 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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) Sorbitol (UNII: 506T60A25R) Aloe Vera Leaf (UNII: ZY81Z83H0X) Peppermint Oil (UNII: AV092KU4JH) Product Characteristics Color GREEN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 138 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 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M022 01/01/2022 SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA
menthol, unspecified form kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76357-410 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-410-01 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 MOUTH SORE SOLUTION 1
mouthwashes and breath fresheners (liquids and sprays) [oral products] liquidProduct Information Route of Administration DENTAL Other Ingredients Ingredient Kind Ingredient Name Quantity COLR White () INGR Water (UNII: 059QF0KO0R) INGR Sodium Benzoate (UNII: OJ245FE5EU) INGR Benzoic Acid (UNII: 8SKN0B0MIM) INGR Sodium Chlorite (UNII: G538EBV4VF) 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 MOUTH SORE SOLUTION 2
menthol, unspecified form liquidProduct Information Item Code (Source) NDC:76357-490 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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) Sorbitol (UNII: 506T60A25R) Aloe Vera Leaf (UNII: ZY81Z83H0X) Peppermint Oil (UNII: AV092KU4JH) Product Characteristics Color GREEN Score Shape Size Flavor 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)
