FDA label 43f76864-413a-d235-e063-6394a90a8e1e

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)

SPL set ID
3469ec91-abf1-41c7-b67c-46335e9cbd70
SPL ID
43f76864-413a-d235-e063-6394a90a8e1e
Version
6
Effective date
2025-11-19
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:25:23

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 This product contains benzocaine. The use of benzocaine applied to the mouth or gums has been associated with methemoglobinemia (a condition where the amount of oxygen in the blood stream is reduced). Stop using immediately if you experience any of the following symptoms and seek medical attention: Pale, gray or blue colored skin, lips, or nail beds Headache or lightheadedness Ask a doctor if: Sore mouth symptoms do not improve in 7 days Irritation, pain or swelling persists or worsens When using this product: NeutraCaine® must be mixed with water before use NeutraCaine® rinse should not be swallowed NeutraCaine® rinse should be spit out after use If pregnant or breast feeding, ask a health professional before use Keep out of reach of children If swallowed, immediately call Poison Control Center or doctor.

Reported adverse events (FAERS/openFDA)#

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