Home FDA labels ceb51341-d42e-f924-e053-2a95a90ab499 FDA label ceb51341-d42e-f924-e053-2a95a90ab499 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 a29f5b9e-6f63-46fb-8417-64906aaf005b
SPL ID ceb51341-d42e-f924-e053-2a95a90ab499
Version 6
Effective date 2021-10-19
Source export date 2026-10-12
Source partition 1
Source file https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:26:35 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
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 Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. For external use only. Not intended for use by children under 13 years of age
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.