FDA.reportPublic FDA data

Urea 40

Manufacturer
SSG Ventures Inc
Effective date
2021-04-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:40:51

Label at a glance#

ProductUrea 40
Active ingredientUREA
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

UREA 40%

OTC - PURPOSE SECTION

SOOTHES ROUGH & DRY SKIN

HEALS CORNS & CALLOUSES

INDICATIONS & USAGE SECTION

SOOTHES ROUGH & DRY SKIN

SAFE HANDLING WARNING SECTION

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.

KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

INSTRUCTIONS FOR USE SECTION

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

INACTIVE INGREDIENT SECTION

PRESERVED WATER, MINERAL OIL, PROPYLENE GLYCOL, TRIETHANOLAMINE, COCONUT OIL, EMULTHIX, CARBOMER, XANTHAM GUM, TEA TREE OIL, ALOE VERA, METHYLPARABEN, PROPYLPARABEN

STORAGE AND HANDLING SECTION

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

OTHER SAFETY INFORMATION

ENHANCED WITH TEA TREE OIL & ALOE VERA

DOSAGE & ADMINISTRATION SECTION

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

WARNINGS SECTION

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
349352urea 40 % Topical GelPSN3
349352urea 0.4 MG/MG Topical GelSCD3
349352urea 40 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81376-211-012023-01-30C16284748780-1f386c64a-31c7-0266-e053-dadaa90a7c1aUrea 40
81376-211-032023-01-30C16284748780-1f386c64a-31c7-0266-e053-dadaa90a7c1aUrea 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81376-211-01Urea 40113 mL in 1 JARGEL1133
81376-211-03Urea 40226 mL in 1 BOTTLE, DISPENSINGGEL2263

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81376-211UREA 40 (UREA) GEL [SSG VENTURES INC]3Legacy NDC, 2 package rows20210617_b71138ef-3166-d690-e053-2995a90a92d2.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81376-21181376-211-01, 81376-211-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
XANTHAN GUMTTV12P4NEEIACT
MINERAL OILT5L8T28FGPIACT
COCONUT OILQ9L0O73W7LIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
TEA TREE OILVIF565UC2GIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
UREA8W8T17847WACTIB

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
bf66d0de-71db-1817-e053-2a95a90a08d9b71138ef-3166-d690-e053-2995a90a92d22021-04-07WarningsExact identifier
spl id: bf66d0de-71db-1817-e053-2a95a90a08d9
spl set id: b71138ef-3166-d690-e053-2995a90a92d2

Reported adverse events (FAERS/openFDA)#

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