SMARTMOUTH MOUTHWASH  CLINICAL DDS FORMULA- 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
Clinical DDS™ 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

Other information

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™ & SMART MOUTH™
ARE TRADEMARKS OF & DISTRIBUTED BY:
TRIUMPH PHARMACEUTICALS INC. • ST. LOUIS, MISSOURI 63141

PRINCIPAL DISPLAY PANEL - Kit Cello Pack

H2S ELIMINATOR & Zn+2 ACTIVATOR

smart
mouth™
OTC

Activates Zinc Ions
Blocks Sulfur Gas

Clinical DDS™
ACTIVATED ORAL RINSE™

PRESCRIPTION STRENGTH+
Gingivitis & Bleeding Gums Protection

24HR
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

TOTAL NET WT.
32 FL. OZ. (960 mL)

Principal Display Panel - Kit Cello Pack
SMARTMOUTH MOUTHWASH   CLINICAL DDS FORMULA
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76357-285
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76357-285-011 in 1 CELLO PACK; Type 0: Not a Combination Product10/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 480 mL
Part 21 BOTTLE, PLASTIC 480 mL
Part 1 of 2
SMARTMOUTH   CLINICAL DDS SOLUTION 1
mouthwashes and breath fresheners (liquids and sprays)
Product Information
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
1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC10/01/2018
Part 2 of 2
SMARTMOUTH   CLINICAL DDS SOLUTION 2 MINT
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
1480 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 FINALpart35610/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35610/01/2018
Labeler - Triumph Pharmaceuticals Inc. (017853461)

Revised: 2/2023
Document Id: d9300784-e2ae-423c-9f58-152259b1fc99
Set id: 87057ce9-e3b2-44f5-bac0-951aeecad768
Version: 5
Effective Time: 20230207
 
Triumph Pharmaceuticals Inc.