FDA.reportPublic FDA data

FDA label bb85401c-2d8d-4771-87bd-5c0d970b7dbc

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
aa7dc169-c5c1-49d4-a5ed-794389cf7544
SPL ID
bb85401c-2d8d-4771-87bd-5c0d970b7dbc
Version
2
Effective date
2023-06-21
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:49

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 Do not use ■ in children less than 2 months of age ■ on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of eye contact, flush eyes with water. Stop use and ask a doctor if ■ irritation or rash occurs. These might be signs of a serious condition. ■ condition persists for more than 72 hours Keep out of reach of children. If swallowed, 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.