ProCure 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: ProCure Hydrocortisone 1%
Generic name: HYDROCORTISONE
Manufacturer: Twin Med LLC
Product type: HUMAN OTC DRUG
SPL set ID: 37cdfabc-1fdb-246a-e063-6394a90a008a
SPL ID: 37cdfabc-1fdc-246a-e063-6394a90a008a
Version: 1
Effective date: 2025-06-17
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:16:24

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		ProCure Hydrocortisone 1%	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		Twin Med LLC	openfda.manufacturer_name
ndc	package	55681-018-01	openfda.package_ndc
ndc	product	55681-018	openfda.product_ndc
ndc11	package	55681001801	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		37cdfabc-1fdc-246a-e063-6394a90a008a	id
spl set id		37cdfabc-1fdb-246a-e063-6394a90a008a	set_id
unii		WI4X0X7BPJ	openfda.unii

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 Warnings For external use only Do not use Do not use for the treatment of diaper rash, consult a doctor if you have vaginal discharge, consult a doctor When using this product When using this product avoid contact with eyes do not use more than directed unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator in case of bleeding, consult a doctor promptly Stop use and ask a doctor if 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 do not begin use of any other hydrocortisone products unless you have consulted a doctor

Reported adverse events (FAERS/openFDA)#

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