Benzo-Jel

Manufacturer
Henry Schein, Inc. | DSHealthcare | DENTSPLY Caulk
Effective date
2010-08-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:09:54

Label at a glance#

ProductBenzo-Jel Raspberry
Active ingredientBenzocaine
Label structure8 sections

Storage and handling

Store at controlled room temperature 59°-86°F (15°-30°C).

Label contents#

Full prescribing information#

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

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.

USUAL DOSAGE

DOSAGE & ADMINISTRATION SECTION

For oral mucosal use only as directed by a dentist.

WARNING

WARNINGS SECTION

Keep out of the reach of children.

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59°-86°F (15°-30°C).

SPL UNCLASSIFIED SECTION

Do not use on people with known allergies to benzocaine and PABA compounds.

CAUTION

SPL UNCLASSIFIED SECTION

Federal law (USA) prohibits dispensing without prescription.

SPL UNCLASSIFIED SECTION

Distributed By:
HENRY SCHEIN INC.
Melville, NY 11747

PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HENRY SCHEIN®

BENZO-JEL™
TOPICAL ANESTHETIC GEL

Raspberry Flavor

20% Benzocaine
FOR PROFESSIONAL USE ONLY
1 FL. OZ. (29.6 mL)

PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053444BENZO-JEL 20 % Oral GelPSN1
238910benzocaine 20 % Oral GelPSN1
1053444benzocaine 0.2 MG/MG Oral Gel [Benzo-Jel]SBD1
238910benzocaine 0.2 MG/MG Oral GelSCD1
1053444Benzo-Jel 0.2 MG/MG Oral GelSY1
1053444Benzo-Jel 20 % Oral GelSY1
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0404-3416-012019-10-21C16284748780-1956f9ecf-d9d7-621f-e053-dbdaa90a74adBENZO-JEL™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-3416-01Benzo-Jel Raspberry34 g in 1 BOTTLEGEL, DENTIFRICE341

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-3416BENZO-JEL (BENZOCAINE) GEL, DENTIFRICE [HENRY SCHEIN, INC.]1Legacy NDC, 1 package rows20100830_07d8c4da-2c28-4aae-a129-03aae15b2991.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW51
BenzocaineACTIVE MOIETYU3RSY48JW51

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-34160404-3416-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
BenzocaineU3RSY48JW5ACTIB

Source Document#

Source XML · Source PDF

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
75566fd9-461f-4f06-bb64-2ef6bca44f7407d8c4da-2c28-4aae-a129-03aae15b29912010-08-27WarningsExact identifier
spl id: 75566fd9-461f-4f06-bb64-2ef6bca44f74
spl set id: 07d8c4da-2c28-4aae-a129-03aae15b2991

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.