SMARTMOUTH GUM AND PLAQUE FORMULA- cetylpyridinium chloride kit

SmartMouth by

Drug Labeling and Warnings

SmartMouth by is a Otc medication manufactured, distributed, or labeled by Triumph Pharmaceuticals Inc., Continental Manufacturing Chemist 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 (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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC.
ST. LOUIS, MISSOURI 63114

PRINCIPAL DISPLAY PANEL - 473 ML Kit Carton

NEW!

PATENTED
DUAL POUR SPOUT™

Activated!

2 Solutions
Working
Together

smart
mouth™

Gum & Plaque
ACTIVATED MOUTHWASH™
HELPS PREVENT GUM DISEASE

24HR
FRESH BREATH
GUARANTEED*

ADVANCED
CLINICAL

Clinically Proven to Prevent Bad Breath for 12 Hours with Each Rinse (*Use 2X Daily)

Advanced Germ Killing. Treats Receding Gums, Gingivitis, Plaque & Medication Breath

CLEAN MINT ALCOHOL FREE NET WT. 16 FL. OZ. (473 ML)

INGREDIENTS AND APPEARANCE

SMARTMOUTH   GUM AND PLAQUE FORMULA
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76357-209

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76357-209-09	1 in 1 CELLO PACK	09/28/2015	08/01/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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)

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)

Product Characteristics
color	WHITE	C48325

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		236.5 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		09/28/2015	08/01/2021

Part 2 of 2

SMARTMOUTH   GUM AND PLAQUE SOLUTION 2 MINT
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)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		236.5 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 NOT FINAL	part356	09/28/2015	08/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/28/2015	08/01/2021

Labeler - Triumph Pharmaceuticals Inc. (017853461)

Establishment
Name	Address	ID/FEI	Business Operations
Continental Manufacturing Chemist Inc.		005278007	MANUFACTURE(76357-209) , LABEL(76357-209) , PACK(76357-209)