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

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

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+

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

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 • 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

SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76357-250

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76357-250-09	1 in 1 CELLO PACK	09/28/2015

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
COLR	White ()
INGR	Water (UNII: 059QF0KO0R)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Sodium Chlorite (UNII: G538EBV4VF)
INGR	Benzoic Acid (UNII: 8SKN0B0MIM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		236.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		09/28/2015

Part 2 of 2

SMARTMOUTH GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquid

Product Information
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	500 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		236.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	09/28/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	09/28/2015

SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76357-255

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76357-255-01	1 in 1 CELLO PACK	02/01/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
COLR	White ()
INGR	Water (UNII: 059QF0KO0R)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Sodium Chlorite (UNII: G538EBV4VF)
INGR	Benzoic Acid (UNII: 8SKN0B0MIM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		02/01/2018

Part 2 of 2

SMARTMOUTH GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquid

Product Information
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	500 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	02/01/2018

SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76357-210

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76357-210-01	1 in 1 CELLO PACK	12/02/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
COLR	White ()
INGR	Water (UNII: 059QF0KO0R)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Sodium Chlorite (UNII: G538EBV4VF)
INGR	Benzoic Acid (UNII: 8SKN0B0MIM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		12/02/2020

Part 2 of 2

SMARTMOUTH GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquid

Product Information
Item Code (Source)	NDC:76357-290
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	500 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76357-290-01	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	12/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	12/02/2020

SMARTMOUTH CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76357-211

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76357-211-01	1 in 1 CELLO PACK	01/01/2023

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
COLR	White ()
INGR	Water (UNII: 059QF0KO0R)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Sodium Chlorite (UNII: G538EBV4VF)
INGR	Benzoic Acid (UNII: 8SKN0B0MIM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/01/2023

Part 2 of 2

SMARTMOUTH GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquid

Product Information
Item Code (Source)	NDC:76357-291
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	500 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	01/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	01/01/2023

Labeler - Triumph Pharmaceuticals Inc. (017853461)

SmartMouth™ Mouthwash Gum & Plaque Formula

Active Ingredient

Purpose

Uses

Warnings

Directions

Other information

Inactive Ingredients

Questions or comments

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - Oral Rinse

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - Breath Rinse

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 320 mL Bottle Label

SmartMouth™ Mouthwash
Gum & Plaque Formula