FDA label 5643f8bd-b0f0-665c-e063-6394a90afabb

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
5643f850-e0d4-d8d8-e063-6294a90a4260
SPL ID
5643f8bd-b0f0-665c-e063-6394a90afabb
Version
1
Effective date
2026-07-10
Source export date
2026-10-27
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/a758d73d4d838a965005e6adf01b928e2da86f99be0f8bbaeeb95f3b7acbe418/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 19:59:19

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. for external anal itching if rectal bleeding occurs. Consult a doctor promptly. When using this product do not get into the eyes for external anal itching, 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. 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.