FDA.reportPublic FDA data

FDA label 115cfc1d-8430-75b4-e063-6394a90a7a63

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
4b6a8f23-bc1b-4cc3-be84-b91ad0f5e60e
SPL ID
115cfc1d-8430-75b4-e063-6394a90a7a63
Version
8
Effective date
2024-02-14
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:14:32

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. If pregnant or breastfeeding consult a healthcare professional before use. Do not use on children 2 years of age unless directed by a doctor. When using this product avoid contact with eyes Use only as directed by a doctor on persons with highly sensitive skin. Stop use and consult a doctor if there is no improvement within 4 weeks irritation occurs Keep out of children. If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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