FDA label acade163-15ed-48e0-bae8-716474176abf

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
96a2d2c6-cc01-4df3-a572-fff39334d91e
SPL ID
acade163-15ed-48e0-bae8-716474176abf
Version
1
Effective date
2017-08-28
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:43

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 • avoid contact with the eyes • do not begin use of any other hydrocortisone product unless you have asked a doctor • for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. • do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days 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.