FDA label 381135be-091e-31ba-e063-6394a90ab84c

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)

SPL set ID
352199d1-d006-48b1-a940-1ba4b0011e54
SPL ID
381135be-091e-31ba-e063-6394a90ab84c
Version
10
Effective date
2025-06-21
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:38:45

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 F. 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 consulted by a doctor in or near the eyes for diaper rash When using this product avoid contact with 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 Keep out of 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.