Benzo Jel

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Benzo Jel
Generic name
BENZOCAINE
Manufacturer
Henry Schein Inc.
Product type
HUMAN OTC DRUG
SPL set ID
2cd571fc-30ee-40da-a2c7-25adb7d4b5c3
SPL ID
1172e39c-cc41-33c5-e063-6294a90a8d4b
Version
6
Effective date
2024-02-15
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:32:25
Harmonized routes table
Harmonized routes
DENTAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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

Reported adverse events (FAERS/openFDA)#

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