Dosage and administration
adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve pain children under 2 years of age: do not use
adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve pain children under 2 years of age: do not use
Store at 59 - 86ºF (15 - 30ºC). Protect from freezing.
Benzocaine 200 mg
Oral Anesthetic
For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
Allergy alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
Sore throat warning:If sore throat is severe,persists for more than 2 days,is accompanied or followed by fever, headache, rash, swelling, nausea,or vomiting, consult a doctor promptly.If sore mouth symptoms do not improve in 7 days, or if irritation,pain, or redness persist or worsen, see your dentist or doctor promptly.
When using this product Avoid contact with eyes. If contact occurs, flush with water.
If pregnant or breast feeding, consult a doctor before use.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.
flavoring, PEG 3350, PEG 400, sucralose. May contain D&C Red #33, FD&C Red #40, D&C Green #5, FD&C Yellow #5 as a color additive.
800-621-2178
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 238910 | benzocaine 20 % Oral Gel | PSN | 3 |
| 1920976 | Sensicaine 20 % Oral Gel | PSN | 3 |
| 1920976 | benzocaine 0.2 MG/MG Oral Gel [Sensicaine] | SBD | 3 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | 3 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | 3 |
| 1920976 | Sensicaine 0.2 MG/MG Oral Gel | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67239-0213-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f04c-f424-e053-dadaa90a57ce | SensiCaine TM Extra Topical Anesthetic Gel Mint Flavor |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67239-0213-1 | Sensicaine TM ExtraTopical Anesthetic | 29 g in 1 JAR | GEL | 29 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67239-0213 | SENSICAINE TM EXTRA TOPICAL ANESTHETIC (BENZOCAINE) GEL [SAFCO DENTAL SUPPLY CO.] | 3 | Legacy NDC, 1 package rows | 20181219_a18e79d7-fd7d-4c97-b004-7fcb12ded046.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67239-0213 | 67239-0213-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
| Polyethylene Glycol 3350 | G2M7P15E5P | IACT |
| Polyethylene Glycol 400 | B697894SGQ | IACT |
| Sucralose | 96K6UQ3ZD4 | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| D&C GREEN NO. 5 | 8J6RDU8L9X | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
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 |
|---|---|---|---|---|---|---|
| 2a6969de-dead-4db2-9591-5b78a17b5b64 | a18e79d7-fd7d-4c97-b004-7fcb12ded046 | 2018-11-11 | Warnings | 2a6969de-dead-4db2-9591-5b78a17b5b64 a18e79d7-fd7d-4c97-b004-7fcb12ded046 |
Adverse event summaries are temporarily unavailable. Other product information remains available.