SMARTMOUTH  ADVANCED CLINICAL DDS FORMULA MINT (ACF)- 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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SmartMouth™ Mouthwash

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 (10 mL from each bottle) 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

SMARTMOUTH™ IS A TRADEMARK OF AND DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC. • ST. LOUIS, MISSOURI 63141

PRINCIPAL DISPLAY PANEL - Kit Carton

smart
mouth™

OTC

Combine
in Cup to
ACTIVATE

2-Bottle Activated System

ELIMINATES
Existing Sulfur Gas

BLOCKS
New Sulfur Gas

Clinical DDS™

CLEAN MINT

TOTAL NET WT.
16 FL. OZ.
(474 mL)

Principal Display Panel - Kit Carton
SMARTMOUTH   ADVANCED CLINICAL DDS FORMULA MINT (ACF)
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-280
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76357-280-011 in 1 CARTON; Type 0: Not a Combination Product02/01/201805/01/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 240 mL
Part 21 BOTTLE, PLASTIC 240 mL
Part 1 of 2
SMARTMOUTH   ADVANCED CLINICAL FORMULA ELIMINATOR (SOLUTION 1)
mouthwashes and breath fresheners (liquids and sprays)
Product Information
Route of AdministrationDENTAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWater (UNII: 059QF0KO0R)  
INGRSodium Benzoate (UNII: OJ245FE5EU)  
INGRSodium Chlorite (UNII: G538EBV4VF)  
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
COSMETIC02/01/201805/01/2022
Part 2 of 2
SMARTMOUTH   ADVANCED CLINICAL FORMULA ACTIVATOR (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)  
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
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 FINALpart35602/01/201805/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/01/201805/01/2022
Labeler - Triumph Pharmaceuticals Inc. (017853461)

Revised: 12/2020
 
Triumph Pharmaceuticals Inc.