FDA.reportPublic FDA data

Thera plus Anti-itch with aloe Hydrocortisone

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
Thera plus Anti-itch with aloe Hydrocortisone
Generic name
HYDROCORTISONE
Manufacturer
Fourstar Group USA, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
c69d0670-a65b-1680-e053-2995a90a2ee5
SPL ID
08a0f5fb-bc99-45d2-e063-6294a90a623c
Version
2
Effective date
2023-10-26
Source export date
2026-08-01
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:26:48
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes. do not use more than directed unless told to do so by a doctor. do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persists for more than 7 days or clear up and occur again within a few days, and do not begin use any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.