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SmartMouth Advance Clinical Formula Cinnamon

Dosage form: kit
Ingredients: ; Cetylpyridinium Chloride 0.05mL in 20mL
Labeler: Triumph Pharmaceuticals Inc.
NDC Code: 76357-212

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.

Smart
Mouth™
ADVANCED
CLINICAL FORMULA™
FRESH CINNAMON

Drug Facts

Active Ingredient

Cetylpyridinium Chloride 0.05% (when mixed as directed)

Purpose

Anti-gingivitis/Anti-plaque

Uses
  • Helps prevent plaque that leads to
    • Gingivitis, an early form of gum disease
    • Bleeding gums

Warnings

Stop use and ask a dentist if :

  • Gingivitis, bleeding, or redness persists for more than 2 weeks.
  • You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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 (5 pumps each of Solution 1 and Solution 2) between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • 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 Red No. 40

Questions or comments

1-800-492-7040

SmartMouth™ is a trademark of and distributed by:
Triumph Pharmaceuticals Inc.
St. Louis, Missouri 63132 Made in USA ©2011

PRINCIPAL DISPLAY PANEL - 2 Bottle Carton

Smart
Mouth™

ADVANCED
CLINICAL FORMULA™

ACTIVATED
MOUTHWASH™

12
HOUR
FRESH
BREATH™
+
ADVANCED
GERM KILLING

ANTI-GINGIVITIS
ANTI-PLAQUE

FRESH CINNAMON
ALCOHOL FREE

NET WT. 16 FL. OZ. (480 mL)
2 BOTTLE SYSTEM

SMARTMOUTH   ADVANCE CLINICAL FORMULA CINNAMON
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-212
Packaging
#Item CodePackage Description
1NDC:76357-212-071 KIT (KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 240 mL
Part 21 BOTTLE, PLASTIC 240 mL
Part 1 of 2
SOLUTION 1 
cetylpyridinium chloride liquid
Product Information
Route of AdministrationDENTALDEA Schedule    
Inactive Ingredients
Ingredient NameStrength
Sodium Chlorite0.01925 mL  in 20 mL
Water 
Sodium Benzoate 
Benzoic Acid 
Product Characteristics
ColorWHITE (Clear Water) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1240 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/25/2011
Part 2 of 2
SOLUTION 2 
cetylpyridinium chloride liquid
Product Information
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetylpyridinium Chloride (Cetylpyridinium) Cetylpyridinium Chloride0.05 mL  in 20 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sodium Benzoate 
Benzoic Acid 
Glycerin 
Poloxamer 407 
Propylene Glycol 
Poloxamer 124 
Zinc Chloride 
Sodium Benzoate 
Saccharin Sodium 
Sodium Chloride 
Benzyl Alcohol 
D&C Yellow No. 10 
FD&C Red No. 40 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCINNAMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1240 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/25/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/25/2011
Labeler - Triumph Pharmaceuticals Inc. (017853461)

Revised: 06/2011
 
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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