FDA label ccecee2e-8dc5-4d0a-9bbe-a38da57be80e

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
e0d12acd-6e99-417d-a983-231e13bc1dd2
SPL ID
ccecee2e-8dc5-4d0a-9bbe-a38da57be80e
Version
2
Effective date
2021-02-25
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:12

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 • for external genital itching – if you have a vaginal discharge, consult a doctor. When using this product • avoid contact with eyes • do not begin the use of any other hydrocortisone product unless you have consulted a doctor • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor • 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 • If symptoms persist for more than 7 days or clear up and reoccur, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor. Keep out of the reach of children. • Do not use if pregnant or breastfeeding.

Reported adverse events (FAERS/openFDA)#

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