FDA.reportPublic FDA data

Clear 50 Nail Gel

Manufacturer
SSG Ventures Inc
Effective date
2021-04-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:01

Label at a glance#

ProductClear 50 Nail Gel
Active ingredientUREA
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

OTC - ACTIVE INGREDIENT SECTION

Urea 50%

OTC - PURPOSE SECTION

WITH THE POWER OF UREA, THIS NAIL GEL REDUCES NAIL THICKNESS AND CLEARS REMNANTS OF DEAD TISSUE FROM THE NAIL BED. ALLOWS ANTI-FUNGAL MEDICATIONS TO PENETRATE AND WORK MORE EFFECTIVELY. SUITABLE FOR FINGERNAILS AND TOENAILS

INDICATIONS & USAGE SECTION

FOR DAMAGED AND THICKENED NAILS

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

WATER, PROPYLENE GLYCOL, TEA TREE OIL POLYSORBATE 20, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PROPYLPARABEN

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477225urea 50 % Topical GelPSN2
477225urea 0.5 MG/MG Topical GelSCD2
477225urea 50 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81376-611-012023-01-30C16284748780-1f386c64a-3eef-0266-e053-dadaa90a7c1aClear 50 Nail Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81376-611-01Clear 50 Nail Gel30 mL in 1 BOTTLE, WITH APPLICATORGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81376-611CLEAR 50 NAIL GEL (UREA) GEL [SSG VENTURES INC]2Legacy NDC, 1 package rows20210428_bb6751ad-342a-9cdd-e053-2995a90a9dd4.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81376-61181376-611-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
TEA TREE OILVIF565UC2GIACT
POLYSORBATE 207T1F30V5YHIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
PROPYLPARABENZ8IX2SC1OHIACT
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
c0f5efa0-4ab2-0794-e053-2a95a90a6e8bbb6751ad-342a-9cdd-e053-2995a90a9dd42021-04-27WarningsExact identifier
spl id: c0f5efa0-4ab2-0794-e053-2a95a90a6e8b
spl set id: bb6751ad-342a-9cdd-e053-2995a90a9dd4

Reported adverse events (FAERS/openFDA)#

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