FDA.reportPublic FDA data

FDA label f3993e03-b5be-442c-a50c-35731b8ec72c

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
e74fdb95-0c12-405e-af7b-a7a691feddec
SPL ID
f3993e03-b5be-442c-a50c-35731b8ec72c
Version
3
Effective date
2023-03-15
Source export date
2026-10-12
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/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:33:34

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 external feminine itching if you have a vaginal discharge. Consult a doctor. • for the treatment of diaper rash. Consult a doctor. When using this produc t • avoid contact with the eyes • do not begin the use of any other hydrocortisone product unless directed by a doctor • for external anal itching: • do not use more than directed by 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 • symptoms last for more than 7 days • the condition gets worse • symptoms clear up and occur again in a few days • rectal bleeding occurs, consult doctor promptly

Reported adverse events (FAERS/openFDA)#

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