UREA 40 NAIL GEL- urea gel

Urea 40 Nail Gel by

Drug Labeling and Warnings

Urea 40 Nail Gel by is a Otc medication manufactured, distributed, or labeled by SSG Ventures Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

UREA 40 NAIL GEL 
urea gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81376-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	12 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)

Product Characteristics
Color	white (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81376-600-01	30 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	10/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/07/2019

Labeler - SSG Ventures Inc (047626115)

Establishment
Name	Address	ID/FEI	Business Operations
SSG Ventures Inc		047626115	manufacture(81376-600)