Hydrocortisone 1%

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)

Brand name
Hydrocortisone 1%
Generic name
HYDROCORTISONE
Manufacturer
Trifecta Pharmaceuticals Usa Llc
Product type
HUMAN OTC DRUG
SPL set ID
9a23c992-2df9-4bef-9409-47805eecfacd
SPL ID
298f35e6-52c9-95c9-e063-6294a90a1f41
Version
9
Effective date
2024-12-18
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:10:38
Harmonized routes table
Harmonized routes
TOPICAL

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 ● avoid contact with the eyes ● do not put this product into the rectum by using fingers or any mechanical device or applicator ● Stop using this product and ask a doctor ● in case of bleeding ● if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ● before you begin using any other hydrocortisone product Do not use this product and ask a doctor ● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age For External Anal Itching Users: ● 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 ● children under 12 years of age: consult a doctor Before using any medication, read all label directions. Keep this carton. It contains important information.

Reported adverse events (FAERS/openFDA)#

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