SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA- menthol, unspecified form kit

SmartMouth by

Drug Labeling and Warnings

SmartMouth by is a Otc medication manufactured, distributed, or labeled by Triumph Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Menthol 0.2% (when mixed as directed)

Purpose

Oral Pain Reliever

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

Do not use this product for more than 7 days unless directed by a dentist or healthcare provider

When using this product do not swallow

• do not exceed recommended dosage

Stop use and see your physician promptly if

• swelling, rash or fever develops
• irritation, pain or redness persists or worsens
• sore mouth symptoms do not improve in 7 days

Keep out of reach of children. 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 & 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?

1-800-492-7040

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 437 mL Kit Cello Pack

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Mouth Sore
Zinc Activated Oral Rinse™

24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Soothes 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

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Mouth Sore
Zinc Activated Breath Rinse™

24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Oral Pain Relief For
CANKER SORES & CHEEK BITES
GUM, BRACES & DENTURE IRRITATION

COOL MINT 16 FL. OZ. (473 mL) ALCOHOL FREE

PRINCIPAL DISPLAY PANEL - 296 mL Kit Cello Pack

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Mouth Sore
Zinc Activated Oral Rinse™

24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Soothes 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 Solutions

smart
mouth™

Mouth Sore
Zinc Activated Oral Rinse™

24
HOUR
BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Soothes 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 kit

Product 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] liquid

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	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 liquid

Product 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 kit

Product 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] liquid

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	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 liquid

Product 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 kit

Product 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] liquid

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	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 liquid

Product 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)