FDA label f3449a7c-6813-4cd1-e053-2995a90a05c8

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
ef50b207-236f-444a-9453-b6d90628ea84
SPL ID
f3449a7c-6813-4cd1-e053-2995a90a05c8
Version
5
Effective date
2023-01-27
Source export date
2026-08-01
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/0689a4374f1490600b5244071db3b04bd3bbc29ceda7a856edb8225323adf20a/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 22:59:39

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 in or near the eyes by putting directly into the rectum by using fingers or any mechanical device or applicator for external feminine itching if you have a vaginal discharge for diaper rash: ask a doctor. Ask a doctor or pharmacist before use if you are using any other hydrocortisone product When using this product for external anal itching, do not exceed recommended daily dosage unless directed by a doctor Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms clear up and return within a few days rectal bleeding occurs Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.