UREA 40 NAIL GEL- urea gel 
SSG Ventures Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Urea 40 Nail Gel

Label

Urea

FOR DAMAGED & THICKENED NAILS

ANTI-FUNGAL

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.

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

KEEP OUT OF REACH OF CHILDREN

APPLY TO AFFECTED NAILS AT LEAST TWICE DAILY OR AS NEEDED

HYDROXYETHYL CELLULOSE NF, PURIFIED WATER, DIMETHYL SULFOXIDE USP

KEEP LID FIRMLY CLOSED

CLOSED IN A COOL DRY PLACE

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

UREA 40 NAIL GEL 
urea gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA12 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
Product Characteristics
Colorwhite (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81376-600-0130 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/07/2019
Labeler - SSG Ventures Inc (047626115)
Establishment
NameAddressID/FEIBusiness Operations
SSG Ventures Inc047626115manufacture(81376-600)

Revised: 2/2021
Document Id: baeaee18-7f11-402e-e053-2a95a90a49f8
Set id: b711b6b3-f4f4-2f76-e053-2a95a90aa815
Version: 2
Effective Time: 20210209
 
SSG Ventures Inc