Home FDA labels b0fb65e3-621d-4c67-b64c-7b06a4bfcf52 FDA label b0fb65e3-621d-4c67-b64c-7b06a4bfcf52 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 da3da8dc-267d-4d14-a35d-7e0e736bd3d4
SPL ID b0fb65e3-621d-4c67-b64c-7b06a4bfcf52
Version 1
Effective date 2015-05-22
Source export date 2026-09-28
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:30:44 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 FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. SOME USERS OF THIS PRODUCT MAY EXPERIENCE SKIN IRRITATION. IF SKIN IRRITATION BECOMES SEVERE, STOP USE AND CONSULT A DOCTOR. DO NOT USE ON CHILDREN UNDER 12 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.