Otc - Active Ingredient
Urea
Urea 40 Nail Gel
FDA Label NDC 71718-600
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scientific Solutions Global Llc for the product Urea 40 Nail Gel (NDC 71718-600). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding package label.principal display panel, otc - active ingredient, otc - purpose, indications & usage, safe handling warning, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
FOR DAMAGED & THICKENED NAILS
ANTI-FUNGAL
Indications & Usage
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
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
KEEP OUT OF REACH OF CHILDREN
Dosage & Administration
APPLY TO AFFECTED NAILS AT LEAST TWICE DAILY OR AS NEEDED
Inactive Ingredient
HYDROXYETHYL CELLULOSE NF, PURIFIED WATER, DIMETHYL SULFOXIDE USP
Storage And Handling
KEEP LID FIRMLY CLOSED
CLOSED IN A COOL DRY PLACE
Warnings
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
* Please review the disclaimer below.
