FDA.reportPublic FDA data

Urea 20

Manufacturer
SSG Ventures Inc
Effective date
2021-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:51

Label at a glance#

ProductUrea 20
Active ingredientUREA
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Inactive Ingredients

COMPONENTS

CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE
GLYCOL, EMULSIFIERS, TRIETHANOLOAMINE

Directions

USER SAFETY WARNINGS SECTION

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

Active Ingredients

COMPONENTS

UREA 20%

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

Indications:

INDICATIONS & USAGE SECTION

SOOTHES ROUGH & DRY SKINSOFTEN NAILSMOISTURIZING GEL

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - ACTIVE INGREDIENT SECTION

UREA

OTC - PURPOSE SECTION

REDUCES CORNS & CALLUSES

SAFETY WARNING :

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
1998617urea 20 % Topical GelPSN2
1998617urea 0.2 MG/MG Topical GelSCD2
1998617urea 20 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81376-210-082023-01-30C16284748780-1f386c64a-20c9-0266-e053-dadaa90a7c1aUrea 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81376-210-08Urea 20113 mL in 1 BOTTLE, DISPENSINGGEL1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81376-210UREA 20 (UREA) GEL [SSG VENTURES INC]2Legacy NDC, 1 package rows20210617_b7112eb7-2ec1-8b17-e053-2995a90a4e1b.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
81376-21081376-210-08

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

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-71da-1817-e053-2a95a90a08d9b7112eb7-2ec1-8b17-e053-2995a90a4e1b2021-04-07WarningsExact identifier
spl id: bf66d0de-71da-1817-e053-2a95a90a08d9
spl set id: b7112eb7-2ec1-8b17-e053-2995a90a4e1b

Reported adverse events (FAERS/openFDA)#

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