Urea Cream 41%

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Urea Cream 41%
Generic name: UREA
Manufacturer: Laser Pharmaceuticals, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: ada4d313-1050-4501-9c93-68dfb3a2c9e4
SPL ID: 42f7100f-e9e2-69fd-e063-6294a90a0f68
Version: 11
Effective date: 2025-11-06
Source export date: 2026-08-01
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run: 20260801T225920Z
Imported at: 2026-08-01 23:23:07

Harmonized routes table
Harmonized routes
TOPICAL

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
brand name		Urea Cream 41%	openfda.brand_name
generic name		UREA	openfda.generic_name
manufacturer name		Laser Pharmaceuticals, LLC	openfda.manufacturer_name
ndc	package	16477-341-08	openfda.package_ndc
ndc	product	16477-341	openfda.product_ndc
ndc11	package	16477034108	derived:openfda.package_ndc
rxcui		1436933	openfda.rxcui
spl id		42f7100f-e9e2-69fd-e063-6294a90a0f68	id
spl set id		ada4d313-1050-4501-9c93-68dfb3a2c9e4	set_id
unii		8W8T17847W	openfda.unii

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

Warnings sections page 1 of 1 · 2 matching rows.

Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.

Urea Cream 41% Rx Only For external use only. Not for ophthalmic use.

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

Adverse reactions sections page 1 of 1 · 1 matching rows.

Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.