Urea 40 Nail Gel: Package Insert and Label Information

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.

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 12 g in 12 g

Inactive Ingredients Ingredient Name Strength WATER DIMETHYL SULFOXIDE HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:81376-600-01 30 g in 1 BOTTLE, WITH APPLICATOR None

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	Operations
SSG Ventures Inc		047626115	manufacture (81376-600)

Revised: 02/2021 SSG Ventures Inc