FDA.reportPublic FDA data

FDA label 58e8c35d-219c-02fd-e063-6294a90a9f90

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
58e8c35d-219b-02fd-e063-6294a90a9f90
SPL ID
58e8c35d-219c-02fd-e063-6294a90a9f90
Version
1
Effective date
2026-08-13
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:28:27

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

Warning For external use only. For adult use only. Test on a small area of external skin before first use. Avoid contact with eyes, internal areas and broken or severely irritated skin. Keep out of reach of children. If a skin concern persists or worsens, consult a healthcare professional. Do not use in children under 18 years of age. if sensitive to any ingredient. inside the urethral opening or to internal or mucosal areas. on broken, bleeding or severely irritated skin. Stop Using and ask a doctor if burning, redness, swelling or discomfort occurs. When Using this product avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.

Reported adverse events (FAERS/openFDA)#

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