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SmartMouth Clinical Gum and Plaque Formula

Dosage form: kit
Ingredients: ; Cetylpyridinium Chloride 500mg in 20mL
Labeler: Triumph Pharmaceuticals Inc.
NDC Code: 76357-250

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SmartMouth™ Mouthwash
Gum & Plaque Formula

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

Double Spout Activates
Both Liquids with a Single Pour!

H2S ELIMINATOR & Zn+2 ACTIVATOR

smart
mouth
OTC

ACTIVATES
Zinc ions when poured

Clinical DDS+
ACTIVATED ORAL RINSE™

Maximum Gingivitis &
Bleeding Gums Protection

PROFESSIONAL
STRENGTH

24 HR
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 • 16 FL. OZ. (473 mL)

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

Double Spout Activates
Both Liquids with a Single Pour!

H2S ELIMINATOR & Zn+2 ACTIVATOR

smart
mouth
OTC

ACTIVATES
Zinc ions when poured

Clinical DDS™
ACTIVATED ORAL RINSE™

Maximum Gingivitis &
Bleeding Gums Protection

PROFESSIONAL
STRENGTH

24 HR
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 • 32 FL. OZ. (946 mL)

Established Pharmacological Class
SubstancePharmacological Class
SmartMouth Gum and Plaque Solution 1MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS)
SmartMouth Gum and Plaque Solution 1MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS)
SMARTMOUTH   CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-250
Packaging
#Item CodePackage Description
1NDC:76357-250-091 KIT in 1 CELLO PACK
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 236.5 mL
Part 21 BOTTLE, PLASTIC 236.5 mL
Part 1 of 2
SMARTMOUTH   GUM AND PLAQUE SOLUTION 1
Product Information
Route of AdministrationDENTALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Sodium Benzoate 
Sodium Chlorite 
Benzoic Acid 
Product Characteristics
colorWHITEC48325
Packaging
#Item CodePackage Description
1236.5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic09/28/2015
Part 2 of 2
SMARTMOUTH   GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquid
Product Information
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetylpyridinium Chloride (Cetylpyridinium) Cetylpyridinium Chloride500 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Poloxamer 407 
Propylene Glycol 
Poloxamer 124 
Zinc Chloride 
Sodium Benzoate 
Benzoic Acid 
Saccharin Sodium 
Sodium Chloride 
Benzyl Alcohol 
D&C Yellow No. 10 
FD&C Blue No. 1 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (mint vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1236.5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/28/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/28/2015
SMARTMOUTH   CLINICAL GUM AND PLAQUE FORMULA
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-255
Packaging
#Item CodePackage Description
1NDC:76357-255-011 KIT in 1 CELLO PACK
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 473 mL
Part 21 BOTTLE, PLASTIC 473 mL
Part 1 of 2
SMARTMOUTH   GUM AND PLAQUE SOLUTION 1
Product Information
Route of AdministrationDENTALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Sodium Benzoate 
Sodium Chlorite 
Benzoic Acid 
Product Characteristics
colorWHITEC48325
Packaging
#Item CodePackage Description
1473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic02/01/2018
Part 2 of 2
SMARTMOUTH   GUM AND PLAQUE SOLUTION 2 MINT
cetylpyridinium chloride liquid
Product Information
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetylpyridinium Chloride (Cetylpyridinium) Cetylpyridinium Chloride500 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Poloxamer 407 
Propylene Glycol 
Poloxamer 124 
Zinc Chloride 
Sodium Benzoate 
Benzoic Acid 
Saccharin Sodium 
Sodium Chloride 
Benzyl Alcohol 
D&C Yellow No. 10 
FD&C Blue No. 1 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (mint vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/01/2018
Labeler - Triumph Pharmaceuticals Inc. (017853461)

Revised: 01/2018
 
Triumph Pharmaceuticals Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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