SMARTMOUTH SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA- cetylpyridinium chloride 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

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Label

NEW &
IMPROVED
POUR

MIXES TO
ACTIVATE
2 Powerful Solutions

BLOCKS
ODORS
FRESHENS
BREATH

smart
mouth™

Gum Health
Scientifically Proven
Smart-Zinc™ Technology

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

INGREDIENTS AND APPEARANCE

SMARTMOUTH   SMARTMOUTH GUM HEALTH ZINC ACTIVATED FORMULA
cetylpyridinium chloride kit

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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)
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

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

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

Labeler - Triumph Pharmaceuticals, Inc. (017853461)