FDA.reportPublic FDA data

Urea 40 Nail Gel

Manufacturer
Scientific Solutions Global LLC
Effective date
2019-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:45

Label at a glance#

ProductUrea 40 Nail Gel
Active ingredientUREA
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UreaNailGelUreaNailGel

OTC - ACTIVE INGREDIENT SECTION

Urea

OTC - PURPOSE SECTION

FOR DAMAGED & THICKENED NAILS

ANTI-FUNGAL

INDICATIONS & USAGE SECTION

WITH THE POWER OF UREA, THIS NAIL GEL REDUCES NAIL THICKNEDD AND PROTECTS THE NAIL FROM FUNGAL GROWTH WHILE CLEARING THE REMNANTS FROM THE NAIL BED.

SMOOTHS ANS EXFOLIATES NAILS.

SUITABLE FOR FINGERNAILS AND TOENAILS.

SAFE HANDLING WARNING SECTION

FOR EXTERNAL USE ONLY.

AVOID CONTACT TO EYES.

KEEP OUT OF REACH OF CHILDREN.

STOP USE AND CONSULT A DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS

KEEP LID FIRMLY CLOSED.

CLOSED IN A COOL DRY PLACE

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION SECTION

APPLY TO AFFECTED NAILS AT LEAST TWICE DAILY OR AS NEEDED

INACTIVE INGREDIENT SECTION

HYDROXYETHYL CELLULOSE NF, PURIFIED WATER, DIMETHYL SULFOXIDE USP

STORAGE AND HANDLING SECTION

KEEP LID FIRMLY CLOSED

CLOSED IN A COOL DRY PLACE

WARNINGS 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 US AND REOCCURS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71718-600-012021-01-29C16284748780-1ba0f9c33-14ca-a910-e053-dadaa90a0b8594554510-d261-75ee-e053-2995a90a1f05

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71718-600-01Urea 40 Nail Gel30 g in 1 BOTTLE, WITH APPLICATORGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71718-600UREA 40 NAIL GEL (UREA) GEL [SCIENTIFIC SOLUTIONS GLOBAL LLC]1Legacy NDC, 1 package rows20191008_94554510-d261-75ee-e053-2995a90a1f05.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71718-60071718-600-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
UREA8W8T17847WACTIB
WATER059QF0KO0RIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT

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
94554510-d262-75ee-e053-2995a90a1f0594554510-d261-75ee-e053-2995a90a1f052019-10-07WarningsExact identifier
spl id: 94554510-d262-75ee-e053-2995a90a1f05
spl set id: 94554510-d261-75ee-e053-2995a90a1f05

Reported adverse events (FAERS/openFDA)#

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