Urea 12% Cream

Manufacturer
Guangzhou Yanxi Biotechnology Co., Ltd
Effective date
2024-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:05

Label at a glance#

ProductUrea 12% Cream
Active ingredientMINERAL OIL, PEG-100 STEARATE
Label structure7 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

use as a normal foot cream

WARNINGS SECTION

keep out of children

INACTIVE INGREDIENT SECTION

Aqua

INDICATIONS & USAGE SECTION

for foot care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of children

OTC - PURPOSE SECTION

moisturize feet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

84025-09184025-091

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84025-091-01Urea 12% Cream100 mL in 1 BOTTLECREAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84025-091UREA 12% CREAM CREAM [GUANGZHOU YANXI BIOTECHNOLOGY CO., LTD]11 package rows20240727_1e1d42a6-526f-062e-e063-6394a90a9638.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84025-09184025-091-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPACTIB
PEG-100 STEARATEYD01N1999RACTIB

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1e1d42a6-5270-062e-e063-6394a90a96381e1d42a6-526f-062e-e063-6394a90a96382024-07-26WarningsExact identifier
spl id: 1e1d42a6-5270-062e-e063-6394a90a9638
spl set id: 1e1d42a6-526f-062e-e063-6394a90a9638

Reported adverse events (FAERS/openFDA)#

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