Indications and uses
Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums
SmartMouth
- Manufacturer
- Triumph Pharmaceuticals Inc.
- Effective date
- 2020-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:58:20
Label at a glance#
ProductSmartMouth Advanced Clinical DDS Formula Mint (ACF)
Active ingredientCetylpyridinium Chloride
Label structure11 sections
Dosage and administration
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.
Storage and handling
This rinse is not intended to replace brushing or flossing.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
SPL UNCLASSIFIED SECTION
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)
Products#
Every source-derived product name is available through these pages.
- SmartMouth Advanced Clinical DDS Formula Mint (ACF)
- Cetylpyridinium Chloride
- SmartMouth Advanced Clinical Formula Eliminator (Solution 1)
- Water
- Sodium Benzoate
- Sodium Chlorite
- Benzoic Acid
- SmartMouth Advanced Clinical Formula Activator (Solution 2)
- CETYLPYRIDINIUM
- Glycerin
- Poloxamer 407
- Propylene Glycol
- Poloxamer 124
- Zinc Chloride
- Saccharin Sodium
- Sodium Chloride
- Benzyl Alcohol
- D&C Yellow No. 10
- FD&C Blue No. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76357-280 | 76357-280-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Water | 059QF0KO0R | INGR |
| Sodium Benzoate | OJ245FE5EU | INGR |
| Sodium Chlorite | G538EBV4VF | INGR |
| Benzoic Acid | 8SKN0B0MIM | INGR |
| Cetylpyridinium Chloride | D9OM4SK49P | ACTIB |
| Water | 059QF0KO0R | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Poloxamer 407 | TUF2IVW3M2 | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Poloxamer 124 | 1S66E28KXA | IACT |
| Zinc Chloride | 86Q357L16B | IACT |
| Sodium Benzoate | OJ245FE5EU | IACT |
| Benzoic Acid | 8SKN0B0MIM | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
| Sodium Chloride | 451W47IQ8X | IACT |
| Benzyl Alcohol | LKG8494WBH | IACT |
| D&C Yellow No. 10 | 35SW5USQ3G | IACT |
| FD&C Blue No. 1 | H3R47K3TBD | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2b2e9dac-4080-4a3d-90d5-74e98805459e | eebcbef6-229b-4c04-81e7-484ae198f874 | 2020-12-30 | Warnings | 2b2e9dac-4080-4a3d-90d5-74e98805459e eebcbef6-229b-4c04-81e7-484ae198f874 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.