Home FDA labels 2a458b2c-3556-7f1e-e063-6294a90a074c hydrocortisone acetate pramoxine HCl 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 acetate pramoxine HCl
Generic name HYDROCORTISONE ACETATE, PRAMOXINE HCL
Manufacturer TRUPHARMA, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID f531fa34-5711-42d0-82c4-3b9943cdcca9
SPL ID 2a458b2c-3556-7f1e-e063-6294a90a074c
Version 4
Effective date 2024-12-27
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 06:25:19 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 · 2 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 Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table <table width="100%"><col width="33%"/><col width="33%"/><col width="33%"/><tbody><tr styleCode="First Toprule"><td valign="top"><paragraph>Burning</paragraph></td><td valign="top"><paragraph>Hypertrichosis</paragraph></td><td valign="top"><paragraph>Maceration of the skin</paragraph></td></tr><tr><td valign="top"><paragraph>Itching</paragraph></td><td valign="top"><paragraph>Acneiform eruptions</paragraph></td><td valign="top"><paragraph>Secondary infection</paragraph></td></tr><tr><td valign="top"><paragraph>Irritation</paragraph></td><td valign="top"><paragraph>Hypopigmentation</paragraph></td><td valign="top"><paragraph>Skin atrophy</paragraph></td></tr><tr><td valign="top"><paragraph>Dryness</paragraph></td><td valign="top"><paragraph>Perioral dermatitis</paragraph></td><td valign="top"><paragraph>Striae</paragraph></td></tr><tr styleCode="Botrule Last"><td valign="top"><paragraph>Folliculitis</paragraph></td><td valign="top"><paragraph>Allergic contact dermatitis</paragraph></td><td valign="top"><paragraph>Miliaria</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.