SMARTMOUTH  ADVANCE CLINICAL FORMULA MINT- cetylpyridinium chloride 
Triumph Pharmaceuticals Inc.

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.

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Smart
Mouth™
ADVANCED
CLINICAL FORMULA™
FRESH MINT

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 Blue No. 1

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 - Kit Carton

NEW LOOK
SAME GREAT FORMULA

smart
mouth™

ACTIVATED
MOUTHWASH®
The Power of 2 Solutions Working Together

ADVANCED CLINICAL FORMULA

12
HOUR
fresh
BREATH
+
MAXIMUM
PLAQUE &
GINGIVITIS
PROTECTION

CLINICALLY PROVEN

To Keep Your Breath Fresh For 12 Hours

2 BOTTLE SYSTEM

ALCOHOL FREE • CLEAN MINT • NET WT. 16 FL. OZ. (480 ML)

PRINCIPAL DISPLAY PANEL - Kit Carton
SMARTMOUTH   ADVANCE CLINICAL FORMULA MINT
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-200
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76357-200-091 in 1 CARTON06/17/201108/31/2018
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 
mouthwashes and breath fresheners (liquids and sprays) liquid
Product Information
Route of AdministrationDENTAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSodium Chlorite (UNII: G538EBV4VF)  
INGRWater (UNII: 059QF0KO0R)  
INGRSodium Benzoate (UNII: OJ245FE5EU)  
INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
Product Characteristics
colorWHITEC48325
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/17/201108/31/2018
Part 2 of 2
SOLUTION 2 
cetylpyridinium chloride liquid
Product Information
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium Chloride500 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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)  
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
ColorGREENScore    
ShapeSize
FlavorMINT (mint vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/17/201108/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/17/201108/31/2018
Labeler - Triumph Pharmaceuticals Inc. (017853461)

Revised: 11/2018
Document Id: dc17ef10-8250-4960-a879-0c706cf41e94
Set id: 5395093c-000d-4e2f-aaab-724f119e3d9b
Version: 3
Effective Time: 20181105
 
Triumph Pharmaceuticals Inc.