Hydrocortisone

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
Generic name
HYDROCORTISONE CONTINUOUS SPRAY
Manufacturer
Premier Brands of America, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
d344f68b-9b62-3029-e053-2995a90a1665
SPL ID
422b3418-94ea-ea94-e063-6294a90ac334
Version
4
Effective date
2025-10-27
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:26:19
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. Flammable: Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. Do not use for external genital, vaginal or anal itching with other hydrocortisone product unless directed by a doctor in or near the eyes for diaper rash When using this product avoid contact with the eyes if product gets into the eye, flush with water for 15 minutes 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 and do not begin use of any other hydrocortisone product unless you have consulted a doctor Keep out of the 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.