FDA label b635e658-12d0-f690-e053-2995a90a2c7b

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
8917ea86-a0d3-dd76-e053-2995a90acadd
SPL ID
b635e658-12d0-f690-e053-2995a90a2c7b
Version
2
Effective date
2020-12-11
Source export date
2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:08

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For external use only do not use for the treatment of diaper rash, except on the advise of a physician When using this product avoid contact with eyes, do not use in or around the eyes Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days. Do not begin use of any other hydrocortisone product unless directed by a physician. Keep out of reach of children . If swallowed, call a Poison Control Centre or get medical help right away.

warnings

Warnings For external use only When using this product do not use on damaged or broken skin keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing Keep out of reach of children . If swallowed, call a Poison Control Centre or get medical help right away.

Reported adverse events (FAERS/openFDA)#

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