Urea 40 Percent Cream

Manufacturer: Method Pharmaceuticals, LLC
Effective date: 2026-02-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 22:06:00

Label at a glance#

ProductUrea 40 Percent

Active ingredientUREA

Label structure10 sections

Dosage and administration

Use as directed by your physician. See label booklet for full Prescribing Information.

Contacts and useful links#

PhoneLabel contact877-250-3427

Label contents#

Full prescribing information#

DESCRIPTION:

DESCRIPTION SECTION

INGREDIENTS: Each gram

of Urea Cream 40%

contains Urea 40% and the

following inactive

ingredients: Carbomer,

Cetearyl Alcohol, Glycerin,

Glyceryl Stearate SE,

Mineral Oil, Purified Water,

White Petrolatum.

desc

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.

Pharmacokinetics:

PHARMACOKINETICS SECTION

The mechanism of action of topically applied urea is not yet known.

INDICATIONS:

INDICATIONS & USAGE SECTION

This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

WARNINGS:

WARNINGS SECTION

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.

Avoid contact with eyes, lips and mucous membranes.

General:

GENERAL PRECAUTIONS SECTION

This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.

Information for Patients:

INFORMATION FOR PATIENTS SECTION

Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

Carcinogenesis, Mutagenesis and Impairment of Fertility:

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.

Pregnancy:

PREGNANCY SECTION

Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers:

NURSING MOTHERS SECTION

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Use as
directed by your physician.
See label booklet for full
Prescribing Information.

STORAGE:

SAFE HANDLING WARNING SECTION

Store at room
temperature 15°C-30°C
(59°F-86°F).
Protect from freezing.
Keep bottle tightly closed.

HOW SUPPLIED:

HOW SUPPLIED SECTION

This product is supplied in the following size(s): 3 oz, 1 oz, and 7oz

To report a serious adverse event or obtain product information, call 877-250-3427

To report a serious adverse event, please contact Method Pharmaceuticals at (877) 250-3427; email at contact@methodpharm.com; or call FDA at (800) FDA-1088.

Manufactured for:

Method Pharmaceuticals, LLC Fort Worth, Texas 76118

Rev. 11/21

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1

label2

label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198342	urea 40 % Topical Cream	PSN	8
198342	urea 400 MG/ML Topical Cream	SCD	8
198342	urea 40 % Topical Cream	SY	8

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0358657487010	GTIN-13: 0358657487010 EAN-13: 0358657487010 GTIN-12: 358657487010 UPC-A: 358657487010 GTIN storage (14 digits): 00358657487010	label1.jpg
Barcode	EAN-13	0358657487034	GTIN-13: 0358657487034 EAN-13: 0358657487034 GTIN-12: 358657487034 UPC-A: 358657487034 GTIN storage (14 digits): 00358657487034	label2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58657-487-01	Urea 40 Percent	28.35 g in 1 BOTTLE	CREAM	28.35	8
58657-487-03	Urea 40 Percent	85 g in 1 BOTTLE	CREAM	85	8
58657-487-07	Urea 40 Percent	198.4 g in 1 BOTTLE	CREAM	198.4	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-487-01	GM - Gram	58657-487	6cc9ad67-4027-4a1a-977f-6cf12e226394	1	2022-02-07
58657-487-03	GM - Gram	58657-487	e3820119-276c-4c8a-8c62-164a4b76514a	1	2022-02-07
58657-487-07	GM - Gram	58657-487	b02e37c2-ec4f-48de-b296-a5fc2cf8097d	1	2022-02-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Urea 40 Percent
Urea
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
CETYL ALCOHOL
WHITE PETROLATUM
MINERAL OIL
WATER
GLYCERYL STEARATE SE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58657-487	58657-487-07, 58657-487-01, 58657-487-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
CETYL ALCOHOL	936JST6JCN	IACT
WHITE PETROLATUM	B6E5W8RQJ4	IACT
MINERAL OIL	T5L8T28FGP	IACT
WATER	059QF0KO0R	IACT
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
UREA	8W8T17847W	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2025-10-21	monthly-update	2026-06-03 17:41:44
6	2024-11-20	full-release	2026-05-31 21:18:04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Urea 40 Percent	UREA	Method Pharmaceuticals, LLC	d35b75e1-937d-ebc4-e053-2a95a90ac0d8	2026-02-12	Warnings, Adverse reactions	Exact identifier ndc (package): 58657-487-01 ndc (package): 58657-487-07 ndc (package): 58657-487-03 ndc (product): 58657-487 ndc11 (package): 58657048703 ndc11 (package): 58657048707 ndc11 (package): 58657048701 spl id: 4aad643a-b8f7-e2cb-e063-6394a90affec spl set id: d35b75e1-937d-ebc4-e053-2a95a90ac0d8

Reported adverse events (FAERS/openFDA)#

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