SMARTMOUTH ADVANCE CLINICAL DDS FORMULA MINT- cetylpyridinium chloride kit

SmartMouth Advance Clinical DDS Formula Mint by

Drug Labeling and Warnings

SmartMouth Advance Clinical DDS Formula Mint 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

• Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse (one sample packet) 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

SPL UNCLASSIFIED SECTION

SMARTMOUTH™ IS A TRADEMARK
OF AND DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC.
ST. LOUIS, MISSOURI 63141

PRINCIPAL DISPLAY PANEL - Kit Pouch

H2S ELIMINATOR∞ & Zn+2 ACTIVATOR

smart
mouth™
OTC

Activates Zinc Ions
Blocks Sulfur Gas

Clinical DDS™
ACTIVATED ORAL RINSE™

PRESCRIPTION STRENGTH+
Gingivitis & Bleeding Gums Protection

24HR BAD BREATH
PREVENTION*

AM RINSE = ALL DAY CLEAN BREATH
PM RINSE = ELIMINATES MORNING BREATH

GUARANTEED†

PATENTED FORMULA DENTIST DEVELOPED
CLEAN MINT NO AFTERTASTE ALCOHOL FREE SAFE FOR DIABETICS 0.68 FL. OZ. (20 mL)

INGREDIENTS AND APPEARANCE

SMARTMOUTH ADVANCE CLINICAL DDS FORMULA MINT 
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76357-230

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76357-230-01	1 in 1 POUCH	12/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	10 mL
Part 2	1 POUCH	10 mL

Part 1 of 2

SMARTMOUTH MOUTHWASH ADVANCE CLINICAL DDS FORMULA SOLUTION 1 (H2S ELIMINATOR) 
mouthwashes and breath fresheners (liquids and sprays) liquid

Product Information
Route of Administration	DENTAL

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

Product Characteristics
color	WHITE	C48325

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		12/01/2019

Part 2 of 2

SMARTMOUTH MOUTHWASH ADVANCE CLINICAL DDS FORMULA SOLUTION 2 (ZN PLUS 2 ACTIVATOR) 
cetylpyridinium chloride liquid

Product Information
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)
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)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT (mint vanilla)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/01/2019

Labeler - Triumph Pharmaceuticals, Inc. (017853461)