Indications and uses
AIDS IN THE PREVENTION OF DENTAL CAVITIES.
AIDS IN THE PREVENTION OF DENTAL CAVITIES.
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH A TOOTHPASTE. VIGOROUSLY SWISH 10 ML OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE AND THEN SPIT OUT. DO NOT SWALLOW THE RINSE. DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING. SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER 12 YEARS OF AGE: CONSULT A DENTIST OR DOCTOR.
STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F). COLD WEATHER MAY CLOUD THIS PRODUCT.
SODIUM FLUORIDE 0.02% (0.01% W/V FLUORIDE ION)
ANTICAVITY
AIDS IN THE PREVENTION OF DENTAL CAVITIES.
KEEP OUT OF REACH OF CHILDREN. IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222).
IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222).
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH A TOOTHPASTE. VIGOROUSLY SWISH 10 ML OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE AND THEN SPIT OUT. DO NOT SWALLOW THE RINSE. DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING. SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER 12 YEARS OF AGE: CONSULT A DENTIST OR DOCTOR.
STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F). COLD WEATHER MAY CLOUD THIS PRODUCT.
WATER (AQUA), SORBITOL, ALCOHOL (21.6%), POLOXAMER 407, SODIUM LAURYL SULFATE, EUCALYPTOL, FLAVOR, METHYL SALICYLATE, THYMOL, PHOSPHORIC ACID, SUCRALOSE, MENTHOL, DISODIUM PHOSPHATE, RED 40 (CI 16035), BLUE 1 (CI 42090).
1-800-842-7886
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 313029 | sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse | PSN | 1 |
| 313029 | sodium fluoride 0.2 MG/ML Mouthwash | SCD | 1 |
| 313029 | sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse | SY | 1 |
| 313029 | sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse | SY | 1 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49738-552-34 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9475-f424-e053-dadaa90a57ce | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49738-552-34 | SMART SENSEANTICAVITY | 1000 mL in 1 BOTTLE, PLASTIC | LIQUID | 1000 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| EUCALYPTOL | INACTIVE INGREDIENT | RV6J6604TK | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| METHYL SALICYLATE | INACTIVE INGREDIENT | LAV5U5022Y | 1 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | 22ADO53M6F | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| THYMOL | INACTIVE INGREDIENT | 3J50XA376E | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49738-552 | 49738-552-34 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| EUCALYPTOL | RV6J6604TK | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| THYMOL | 3J50XA376E | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | IACT |
| FD&C RED NO. 40 | WZB9127XOA | 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 |
|---|---|---|---|---|---|---|
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, SUSPENSION / INTRALESIONAL | 3 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | AEROSOL, FOAM / VAGINAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | CAPSULE, DELAYED RELEASE / ORAL | 43 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | AEROSOL, FOAM / TOPICAL | 0.09 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SHAMPOO, SUSPENSION / TOPICAL | 40 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| THYMOL | THYMOL | 3J50XA376E | LIQUID / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, SUSPENSION / INTRASYNOVIAL | 3 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION / INTRAMUSCULAR | 1751 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | SUSPENSION / OPHTHALMIC | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | DROPS / NASAL | 40.32 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | TABLET, EXTENDED RELEASE / ORAL | 210 mg | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, EXTENDED RELEASE / ORAL | 166 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | LOZENGE / ORAL | 53 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | LOTION / TOPICAL | 71 mg | ||
| EUCALYPTOL | EUCALYPTOL | RV6J6604TK | DROPS / NASAL | 0.2 mg/1ml | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | CAPSULE, DELAYED RELEASE / ORAL | 5 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION / INTRAVENOUS | 381 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | GUM, CHEWING / BUCCAL | 89 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | TABLET / ORAL | 96 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | TABLET, FILM COATED / ORAL | 0.01 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | FILM / BUCCAL | 0.35 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION, CONCENTRATE / ORAL | 0.5 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | GEL / TOPICAL | 28 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION / INTRAMUSCULAR | ADJ PH | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET / SUBLINGUAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | SOLUTION / INTRAVENOUS | 381 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | GRANULE / ORAL | 12 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | SPRAY, METERED / NASAL | 7 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | SOLUTION / OPHTHALMIC | 0.2 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w |
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 |
|---|---|---|---|---|---|---|
| 1c7cb46c-2865-4290-adc4-5a5df3f104c1 | cf6019ae-3b87-4f36-a5a0-05a2a45ed799 | 2013-05-09 | Warnings | 1c7cb46c-2865-4290-adc4-5a5df3f104c1 cf6019ae-3b87-4f36-a5a0-05a2a45ed799 |
Adverse event summaries are temporarily unavailable. Other product information remains available.