Home FDA labels 1cb486db-e980-4ebe-83a1-d8c2b5cdce37 Hydrocortisone Acetate Pramoxine Hcl openFDA label record# Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name Hydrocortisone Acetate Pramoxine Hcl
Generic name HYDROCORTISONE ACETATE PRAMOXINE HCL
Manufacturer Bryant Ranch Prepack
Product type HUMAN PRESCRIPTION DRUG
SPL set ID a6a5e63c-29ca-4d30-b8b6-b3bd18a25c38
SPL ID 1cb486db-e980-4ebe-83a1-d8c2b5cdce37
Version 100
Effective date 2025-10-24
Source export date 2026-08-01
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/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run 20260801T225920Z
Imported at 2026-08-01 23:28:03 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.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria