Home FDA labels 8b784f34-ee71-45f7-9c01-9f737dd4e93c FDA label 8b784f34-ee71-45f7-9c01-9f737dd4e93c 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 bd153021-e76a-437d-be5d-ce9f69493544
SPL ID 8b784f34-ee71-45f7-9c01-9f737dd4e93c
Version 9
Effective date 2021-03-30
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 06:31:09 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 • do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions adverse reactions Distributed By: American Sales Company 4201 Walden Avenue Lancaster, NY 14086 www.care1.info 226.002/226AD
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.