FDA label c8ad60e2-f392-9d3b-e053-2a95a90a2135

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
912e8c82-570c-b6e6-e053-2995a90ae31a
SPL ID
c8ad60e2-f392-9d3b-e053-2a95a90a2135
Version
3
Effective date
2021-08-03
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:56:25

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 (Hydrocortisone Cream) For external use only Do not use (Hydrocortisone cream) • in the eyes • for treatment of diaper rash • for feminine itching Ask a doctor before use if you are (Hydrocortisone cream) • using any other hydrocortisone product Stop use and ask a doctor if (Hydrocortisone cream) the condition worsens or lasts more than 7 days, or clears up and occurs again within a few days Keep out of reach of children (Hydrocortisone cream) If ingested, contact a Poison Control Center right away

warnings

Warnings (Diphen caplet) Do not use • to make children sleepy • with any other product containing diphenhydramine, even one that is used on skin. Ask a doctor before use if you have (Diphen caplet) • a breathing problem such as emphysema or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland • glaucoma When using this product (Diphen caplet) • marked drowsiness may occur • avoid alcohol beverages • alcohol, sedatives and tranquilizers may increase the drowsiness effect • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children If pregnant or breast-feeding (Diphen caplet) ask a health care professional before use. Keep out of reach of children (Diphen caplet) n case of overdose, contact a physician or poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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