FDA label 5d26b6fc-7a79-a45b-e063-6294a90a2183

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
aaf91c65-8460-49a6-a331-582b3fb6cdce
SPL ID
5d26b6fc-7a79-a45b-e063-6294a90a2183
Version
3
Effective date
2026-10-06
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:01:20

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 or near the eyes by putting directly into the rectum by using fingers or any mechanical device or applicator for external feminine itching if you have a vaginal discharge for diaper rash; ask a doctor Ask a doctor or pharmacist before use if you are using any other hydrocortisone product When using this product for external anal itching, do not exceed recommended daily dosage unless directed by a doctor Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms clear up and return within a few days rectal bleeding occurs Keep out of reach of children If swallowed, get medical help or contact a Poison Control

Reported adverse events (FAERS/openFDA)#

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