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

Use after your normal brushing and flossing routine
Adults and children 12 years of age & older: vigorously swish 20 mL 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 unless directed by a healthcare professional.

Inactive Ingredients

Solution 1: Purified Water, Sodium Benzoate, Sodium Chlorite, and Benzoic Acid. Solution 2: Purified Water, Glycerin, Poloxamer 407, Propylene Glycol, Aloe Vera, 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?

1-800-492-7040

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

PRINCIPAL DISPLAY PANEL - Kit Label

MIXES TO ACTIVATE
2 Powerful Solutions

smart
mouth™

Gum Health
Zinc Activated Breath Rinse™

24
HOUR

BAD BREATH
PREVENTION
WITH A MORNING & EVENING RINSE

Advanced Germ Killing+
BLEEDING GUMS PROTECTION
SOOTHES WITH NATURAL ALOE

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

SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76357-509

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76357-509-01	1 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	237 mL
Part 2	1 BOTTLE	237 mL

Part 1 of 2

SMARTMOUTH GUM HEALTH SOLUTION 1
mouthwashes and breath fresheners (liquids and sprays) [oral products] liquid

Product Information
Route of Administration	DENTAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
COSMETIC		01/01/2024

Part 2 of 2

SMARTMOUTH GUM HEALTH SOLUTION 2
cetylpyridinium chloride liquid

Product Information
Item Code (Source)	NDC:76357-599
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)
ALOE (UNII: V5VD430YW9)
POLOXAMER 124 (UNII: 1S66E28KXA)
Zinc Chloride (UNII: 86Q357L16B)
SODIUM (UNII: 9NEZ333N27)
Benzoic Acid (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Sodium Chloride (UNII: 451W47IQ8X)
Benzyl Alcohol (UNII: LKG8494WBH)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT (Mild Mint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76357-599-02	237 mL in 1 BOTTLE; 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	01/01/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	01/01/2024

Labeler - Triumph Pharmaceuticals, Inc. (017853461)

SmartMouth™ Mouthwash SmartMouth™ Gum Health Zinc Activated Formula