Urea 40 Nail Gel

Manufacturer: SSG Ventures Inc
Effective date: 2021-02-09
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:38:01

Label at a glance#

ProductUrea 40 Nail Gel

Active ingredientUREA

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

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
NDC	Effective	Action	Document	Indexing SPL	Related label
81376-600-01	2023-01-30	C162847	48780-1	f386c649-b954-0266-e053-dadaa90a7c1a	Urea 40 Nail Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81376-600-01	Urea 40 Nail Gel	30 g in 1 BOTTLE, WITH APPLICATOR	GEL	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81376-600	UREA 40 NAIL GEL (UREA) GEL [SSG VENTURES INC]	2	Legacy NDC, 1 package rows	20210211_b711b6b3-f4f4-2f76-e053-2a95a90aa815.zip

Products#

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

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

Urea 40 Nail Gel
Urea
WATER
DIMETHYL SULFOXIDE
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
81376-600	81376-600-01

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
DIMETHYL SULFOXIDE	YOW8V9698H	IACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	IACT
UREA	8W8T17847W	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
baeaee18-7f11-402e-e053-2a95a90a49f8			b711b6b3-f4f4-2f76-e053-2a95a90aa815	2021-02-09	Warnings	Exact identifier spl id: baeaee18-7f11-402e-e053-2a95a90a49f8 spl set id: b711b6b3-f4f4-2f76-e053-2a95a90aa815

Reported adverse events (FAERS/openFDA)#

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