FDA.reportPublic FDA data

Benzo Jel

Manufacturer
Henry Schein Inc.
Effective date
2024-02-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:08:43

Label at a glance#

ProductBenzo Jel
Active ingredientBENZOCAINE
Label structure11 sections

Indications and uses

For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures. For Professional Use Only.

Storage and handling

Store at room temperature.  Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
  • For Professional Use Only.

Warnings

WARNINGS SECTION

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a setious condition that must be treated promptiy because it reduces the amount of oxygen canied in the blood. This can occur even if you have used this product before. Slop use and seek immediate medical attention tt you or a child in your care develops:

• pale, gray or blue colored skn (cyanosis)
• headache
• rapid heart rate
• shortress of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Flammable. Do not use near fire or flame. Avoid smoking during use.

Do not use:

  • for teething
  • in children under 2 years of age

​Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center nght away. Avoid spraying in eyes.

Dosage

DOSAGE & ADMINISTRATION SECTION

​A single metered spray dispenses 50 mg of Benzo-Jel Topical Anesthetic. Use only as directed by a dentist.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature.  Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethyl Alcohol, Flavor, Polyethelyn Glycol, Sodium Saccharin, Hydrocarbon Propellant (HFC-134a).

​Questions or comments?

OTC - QUESTIONS SECTION

1-800-472-4346

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal DisplayPrincipal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1742420Benzo-Jel 20 % Mucosal SprayPSN6
360348benzocaine 20 % Mucosal SprayPSN6
1742420benzocaine 200 MG/ML Mucosal Spray [Benzo-Jel]SBD6
360348benzocaine 200 MG/ML Mucosal SpraySCD6
1742420Benzo-Jel 20 % Dental SpraySY6
1742420Benzo-Jel 20 % Mucosal SpraySY6
1742420Benzo-Jel 200 MG/ML Mucosal SpraySY6
360348benzocaine 20 % Mucosal SpraySY6

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
0404-0018-352024-01-30C16284748780-11030e365-4dac-111a-e063-dadaa90a10e22cd571fc-30ee-40da-a2c7-25adb7d4b5c3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0018-35Benzo Jel57 g in 1 BOTTLE, SPRAYSPRAY, METERED576

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0018BENZO JEL (BENZOCAINE) SPRAY, METERED [HENRY SCHEIN INC.]6Current NDC, Legacy NDC, 1 package rows20240217_2cd571fc-30ee-40da-a2c7-25adb7d4b5c3.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-00180404-0018-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

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
Benzo JelBENZOCAINEHenry Schein Inc.2cd571fc-30ee-40da-a2c7-25adb7d4b5c32024-02-15WarningsExact identifier
ndc (package): 0404-0018-35
ndc (product): 0404-0018
ndc11 (package): 00404001835
spl id: 1172e39c-cc41-33c5-e063-6294a90a8d4b
spl set id: 2cd571fc-30ee-40da-a2c7-25adb7d4b5c3

Reported adverse events (FAERS/openFDA)#

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