Storage and handling
Store at controlled room temperature 59°-86°F (15°-30°C).
Store at controlled room temperature 59°-86°F (15°-30°C).
Each gram of Benzo-Jel™ 20% benzocaine gel contains between 180-220 mg benzocaine USP, in a water soluble base of PEG 3350 USP, PEG 400 USP, flavor, Sodium Saccharin USP, FD&C Red #28, FD&C Red #40 and FD&C Blue #1.
For oral mucosal use only as directed by a dentist.
Keep out of the reach of children.
Store at controlled room temperature 59°-86°F (15°-30°C).
Do not use on people with known allergies to benzocaine and PABA compounds.
Federal law (USA) prohibits dispensing without prescription.
Distributed By:
HENRY SCHEIN INC.
Melville, NY 11747
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1053444 | BENZO-JEL 20 % Oral Gel | PSN | 1 |
| 238910 | benzocaine 20 % Oral Gel | PSN | 1 |
| 1053444 | benzocaine 0.2 MG/MG Oral Gel [Benzo-Jel] | SBD | 1 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | 1 |
| 1053444 | Benzo-Jel 0.2 MG/MG Oral Gel | SY | 1 |
| 1053444 | Benzo-Jel 20 % Oral Gel | SY | 1 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0404-3416-01 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d9d7-621f-e053-dbdaa90a74ad | BENZO-JEL™ |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0404-3416-01 | Benzo-Jel Raspberry | 34 g in 1 BOTTLE | GEL, DENTIFRICE | 34 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benzocaine | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| Benzocaine | ACTIVE MOIETY | U3RSY48JW5 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0404-3416 | 0404-3416-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 75566fd9-461f-4f06-bb64-2ef6bca44f74 | 07d8c4da-2c28-4aae-a129-03aae15b2991 | 2010-08-27 | Warnings | 75566fd9-461f-4f06-bb64-2ef6bca44f74 07d8c4da-2c28-4aae-a129-03aae15b2991 |
Adverse event summaries are temporarily unavailable. Other product information remains available.