FDA.reportPublic FDA data

FDA label d58ff524-01c2-7574-e053-2995a90a7c52

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
6997ce4b-ead8-00bf-e053-2991aa0a6e08
SPL ID
d58ff524-01c2-7574-e053-2995a90a7c52
Version
9
Effective date
2022-01-14
Source export date
2026-11-06
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:04:45

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

For external use only Do not use on children under 2 years of age unless directed by a doctor Avoid contact with eyes, ears or mouth If irritation occurs, discontinue use and consult a doctor If swallowed, get medical help or consult a poison control center immediately

warnings

Warnings For external use only Do not use on children under 2 years of age unless directed by a doctor Avoid contact with eyes, ears or mouth If irritation occurs, discontinue use and consult a doctor If swallowed, get medical help or consult a poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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