FDA.reportPublic FDA data

FDA label 956b63c9-4ca4-46db-8476-8a7f0590ff36

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
483e58b1-6519-428b-9446-11d3244b2612
SPL ID
956b63c9-4ca4-46db-8476-8a7f0590ff36
Version
3
Effective date
2013-03-26
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:04

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 do not use on children under two years of age except under the advice and supervision of a doctor Stop use and ask a doctor if irritation occurs, if condition worsens, or there is not improvement within four weeks for external use only avoid contact with eyes, scalp, vagina, penis, scrotum and anus do not ingest do not use on open wounds in case of accidental ingestion, contact a physician, emergency medical do not use if you are known to be sensitive to any of the ingredients in this product

Reported adverse events (FAERS/openFDA)#

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