FDA label b06c3c12-c134-487c-aabe-601c4a2af7c4

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
895d81b9-90a3-4a56-838a-68c3d6e4baa7
SPL ID
b06c3c12-c134-487c-aabe-601c4a2af7c4
Version
2
Effective date
2023-03-15
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 02:20:08

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. Not for deep or puncture wounds. Avoid contact with eyes. In case of accidental ingestion contact a physician or poison control center immediately. If condition worsens or does not improve within 7 days, consult a doctor. When using this product • Certain persons can develop allergic reactions to ingredients in this product. • Do not put this product into the rectum by using fingers or any mechanical device or applicator. • Do not exceed the recommended daily dosage unless directed by a doctor. Stop use and ask a doctor if • Bleeding occurs • Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase • Keep out of reach of children

Reported adverse events (FAERS/openFDA)#

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