FDA label 5763b4de-06f3-7b19-e063-6294a90ad068

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
5763b4de-06f2-7b19-e063-6294a90ad068
SPL ID
5763b4de-06f3-7b19-e063-6294a90ad068
Version
1
Effective date
2026-07-24
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 02:01:33

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 for the treatment of diaper rash. Ask a doctor. for external genital itching if you have a vaginal discharge. Ask a doctor. When using this product do not get into the eyes do not use more than directed unless told to do so by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition gets worse, or symtoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product. rectal bleeding occurs Keep out of reach of children ​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.