Skip to Content

SmartMouth Gum and Plaque Formula

Medically reviewed on August 10, 2018

Dosage form: kit
Ingredients: ; Cetylpyridinium Chloride 500mg in 20mL
Labeler: Triumph Pharmaceuticals Inc.
NDC Code: 76357-209

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 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)

Established Pharmacological Class
SubstancePharmacological Class
SmartMouth Gum and Plaque Solution 1MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS)
SMARTMOUTH   GUM AND PLAQUE FORMULA
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-209
Packaging
#Item CodePackage Description
1NDC:76357-209-091 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
Labeler - Triumph Pharmaceuticals Inc. (017853461)
Establishment
NameAddressID/FEIOperations
Continental Manufacturing Chemist Inc.005278007MANUFACTURE(76357-209), LABEL(76357-209), PACK(76357-209)

 
Triumph Pharmaceuticals Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide