SKIN A COOL Hydrocortisone Anti-Itch

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: SKIN A COOL Hydrocortisone Anti-Itch
Generic name: HYDROCORTISONE
Manufacturer: Ana-Cool, LLC
Product type: HUMAN OTC DRUG
SPL set ID: e3ea7406-e494-4038-9b28-8d0a28b4b834
SPL ID: 09d7675e-8ab0-ac1b-e063-6394a90a58bb
Version: 2
Effective date: 2023-11-10
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:17:37

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		SKIN A COOL Hydrocortisone Anti-Itch	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		Ana-Cool, LLC	openfda.manufacturer_name
ndc	package	70288-173-00	openfda.package_ndc
ndc	product	70288-173	openfda.product_ndc
ndc11	package	70288017300	derived:openfda.package_ndc
spl id		09d7675e-8ab0-ac1b-e063-6394a90a58bb	id
spl set id		e3ea7406-e494-4038-9b28-8d0a28b4b834	set_id
unii		WI4X0X7BPJ	openfda.unii

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. Do not use for for the treatment of diaper rash. Consult a doctor. When using this product Avoid contact with the eyes. Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocorstisone product unless you have consulted a doctor. 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.