Indications and uses
HELPS REDUCE AND PREVENT PLAQUE AND GINGIVITIS. HELPS CONTROL PLAQUE BACTERIA THAT CONTRIBUTE TO THE DEVELOPMENT OF GINGIVITIS AND BLEEDING GUMS.
HELPS REDUCE AND PREVENT PLAQUE AND GINGIVITIS. HELPS CONTROL PLAQUE BACTERIA THAT CONTRIBUTE TO THE DEVELOPMENT OF GINGIVITIS AND BLEEDING GUMS.
USE AFTER YOUR NORMAL BRUSHING AND FLOSSING ROUTINE; RINSE TOOTHPASTE FROM MOUTH PRIOR TO USE. ADULTA AND CHILDREN 6 YEARS AND OLDER: RINSE FOR 30 SECONDS WITH 20 ML (4 TEASPOONFULS) TWICE A DAY. DO NOT SWALLOW. CHILDREN 6 YEARS TO UNDER 12 YEARS OF AGE: SUPERVISE USE. CHILDREN UNDER 6 YEARS OF AGE: DO NOT USE.
STORE AT ROOM TEMPERATURE.
CETYLPYRIDINIUM CHLORIDE 0.07%
ANTIPLAQUE/ANTIGINGIVITIS
HELPS REDUCE AND PREVENT PLAQUE AND GINGIVITIS. HELPS CONTROL PLAQUE BACTERIA THAT CONTRIBUTE TO THE DEVELOPMENT OF GINGIVITIS AND BLEEDING GUMS.
ASK A DENTIST IF SYMPTOMS PERSIST OR CONDITION WORSENS AFTER REGULAR USE.
IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222).
USE AFTER YOUR NORMAL BRUSHING AND FLOSSING ROUTINE; RINSE TOOTHPASTE FROM MOUTH PRIOR TO USE. ADULTA AND CHILDREN 6 YEARS AND OLDER: RINSE FOR 30 SECONDS WITH 20 ML (4 TEASPOONFULS) TWICE A DAY. DO NOT SWALLOW. CHILDREN 6 YEARS TO UNDER 12 YEARS OF AGE: SUPERVISE USE. CHILDREN UNDER 6 YEARS OF AGE: DO NOT USE.
STORE AT ROOM TEMPERATURE.
WATER (AQUA), GLYCERIN, POLOXAMER 407, FLAVOR, SODIUM SACCHARIN, METHYLPARABEN, SUCRALOSE, PROPYLPARABEN, BLUE 1 (CI 42090).
1-800-842-7886
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49738-553-34 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ec2c-f424-e053-dadaa90a57ce | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49738-553-34 | SMART SENSEALCOHOL FREE | 1000 mL in 1 BOTTLE, PLASTIC | LIQUID | 1000 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CETYLPYRIDINIUM CHLORIDE | ACTIVE INGREDIENT | D9OM4SK49P | 1 | |
| CETYLPYRIDINIUM | ACTIVE MOIETY | CUB7JI0JV3 | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49738-553 | 49738-553-34 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETYLPYRIDINIUM CHLORIDE | D9OM4SK49P | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | CAPSULE, EXTENDED RELEASE / ORAL | 40 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / TOPICAL | 4 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM, SOLUBLE / ORAL | 33 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | SUSPENSION / INTRATYMPANIC | 63 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | LOTION / TOPICAL | 71 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, CHEWABLE / ORAL | 0.14 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | AEROSOL, FOAM / TOPICAL | 0.04 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | CAPSULE, DELAYED RELEASE / ORAL | 5 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM / ORAL | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYSTEM / TOPICAL | 21 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / NASAL | 140 mg |
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 |
|---|---|---|---|---|---|---|
| cc7d57bf-7b5e-4ad3-8481-40be811f0935 | 2b9d9ce2-4e9d-4f24-9a04-be47b18fe561 | 2013-05-09 | Warnings | cc7d57bf-7b5e-4ad3-8481-40be811f0935 2b9d9ce2-4e9d-4f24-9a04-be47b18fe561 |
Adverse event summaries are temporarily unavailable. Other product information remains available.