FDA.reportPublic FDA data

Urea 40% Cream

Manufacturer
Trivia Pharmaceuticals, LLC | Pure Source, Inc.
Effective date
2026-10-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-20 03:03:15

Label at a glance#

ProductUrea 40
Active ingredientUREA
Label structure12 sections

Storage and handling

Storage:  Store at 20°C (68°F - 77°F). Protect from freezing and excessive heat. Keep container tightly closed.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: UREA 40%

OTC - PURPOSE SECTION

Purpose: Moisturizer

INDICATIONS & USAGE SECTION

Usage: Intensely exfolitating and skin-softening cream with Urea 40%. Helps smooth and soften very, dry, rough, and thickened skin. Suitable for targeted application on areas with very dry, hardened or thick skin, rough patches and calluses, uneven, scaly, or flaky skin texture and thickened nail surface appearance. Helps soften and improve the cosmetic appearance of thickened or irregular nails.

WARNINGS SECTION

Caution: Discontinue use and consult a physician if redness or Irritation occurs.

When using this product avoid contact with eyes, lips or mucous membranes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. For External Use Only.

OTC - DO NOT USE SECTION

Do not use: If allergic to any of the ingredients in the cream.

OTC - WHEN USING SECTION

Directions: Apply Urea 40% Cream to affected area(s) twice per day, or as directed by your physician. Rub in until completely absorbed.

OTC - STOP USE SECTION

Stop Use: Discontinue use and consult a physician if redness or Irritation occurs.

When using this product avoid contact with eyes, lips or mucous membranes.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua), Urea*, Glyceryl Stearate SE, Propylene Glycol, Steraryl Alcohol, Cetyl Alcohol, Mineral Oil (Paraffinum Liquidum), Butyrospermum Parkii (Shea) Butter, Petrolatum, C12-15 Alkyl Benzoate, Phenoxyethanol, Gluconolactone, Polyacrylamide, C13-14 Isoalkane, Xanthan Gum, Ethylhexylglycerin, Citric Acid, Sodium Phytate, Laureth-7, Sodium Citrate

STORAGE AND HANDLING SECTION

Storage: Store at 20°C (68°F - 77°F). Protect from freezing and excessive heat. Keep container tightly closed.

OTC - QUESTIONS SECTION

Questions? Call: 602-834-3759

Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urea 40% Cream

Urea 40Urea 40

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84781-60384781-603-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
UREA8W8T17847WACTIB
WATER059QF0KO0RIACT
GLYCERYL STEARATE230OU9XXE4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MINERAL OILT5L8T28FGPIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PETROLATUM4T6H12BN9UIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLUCONOLACTONEWQ29KQ9POTIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM PHYTATE88496G1ERLIACT
LAURETH-7Z95S6G8201IACT
SODIUM CITRATE1Q73Q2JULRIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT

Source Document#

Source XML

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UREDEXUREABlue Heron Pharmaceuticals, LLC0e4d7b03-527f-4cff-9154-7e5e485a8f802026-07-13Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40UREAKrewe Pharma, LLC415c4efd-95bd-4276-900c-e9da70266cd42026-06-02WarningsName fallback
brand name: Urea 40
generic name: UREA
Urea 39UREAKrewe Pharma, LLCbe19358f-67a8-4a0d-88e0-91eb4cb42e0d2026-06-02WarningsName fallback
generic name: UREA
UREVEXUREABlue Heron Pharmaceuticals, LLC1ed71529-7607-47ff-bd16-3c9a63e1c7332026-04-28Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40 PercentUREABryant Ranch Prepack6701225c-2c2e-41e8-8d43-ef77c00a99462026-04-24Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40 PercentUREABryant Ranch Prepackee06a590-a104-4e97-b66c-cd37869038a52026-03-27Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 40 PercentUREABryant Ranch Prepacke28969bc-c3a0-49e5-9947-aee0c6b8b0b52026-02-13Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40 PercentUREAMethod Pharmaceuticals, LLCd35b75e1-937d-ebc4-e053-2a95a90ac0d82026-02-12Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 40 PercentUREAMethod Pharmaceuticals, LLC0920f780-b504-1fea-e063-6394a90ae5a92026-01-15Warnings, Adverse reactionsName fallback
generic name: UREA
UREAUREABioComp Pharma, Inc.0fb373f8-5328-2f10-e063-6294a90a24842026-01-13Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 20UREAAvPAKe994fa05-a457-2555-e053-2a95a90ae83b2026-01-12WarningsName fallback
generic name: UREA
UREAUREABioComp Pharma, Inc.6774a5ef-9bb0-4e7a-e053-2a91aa0af47f2025-12-17Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 40 PercentUREABryant Ranch Prepack59afcfbe-fe04-49c9-b1c5-28f2c4311c012025-11-12Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 40%UREALaser Pharmaceuticals, LLCef2db58d-e760-417d-8574-45a411c49b472025-11-06Warnings, Adverse reactionsName fallback
generic name: UREA
Urea Cream 41%UREALaser Pharmaceuticals, LLCada4d313-1050-4501-9c93-68dfb3a2c9e42025-11-06Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40 PercentUREABryant Ranch Prepack3d9bf300-cb72-463b-be9a-70c8d9a55b632025-10-29Warnings, Adverse reactionsName fallback
generic name: UREA
UREAUREACintex Services, LLC4137c430-bd2b-07a1-e063-6394a90afed92025-10-15Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 40%UREAPatrin Pharma, Inc53ccf801-c1c6-42c8-a511-da33c308076f2025-08-21Warnings, Adverse reactionsName fallback
generic name: UREA
Urea 41%UREAOncora Pharma, LLC37576876-738c-ac79-e063-6394a90a84fe2025-06-11Warnings, Adverse reactionsName fallback
generic name: UREA
UREAUREABantry Pharma, LLCcb6ddbfc-ea6a-0ddc-e053-2995a90aedc42025-06-04Warnings, Adverse reactionsName fallback
generic name: UREA

Reported adverse events (FAERS/openFDA)#

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