Package Label.Principal Display Panel
Label
Clear 50 Nail Gel
FDA Label NDC 81376-611
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ssg Ventures Inc for the product Clear 50 Nail Gel (NDC 81376-611). 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 - Active Ingredient
Urea 50%
Otc - Purpose
WITH THE POWER OF UREA, THIS NAIL GEL REDUCES NAIL THICKNESS AND CLEARS REMNANTS OF DEAD TISSUE FROM THE NAIL BED. ALLOWS ANTI-FUNGAL MEDICATIONS TO PENETRATE AND WORK MORE EFFECTIVELY. SUITABLE FOR FINGERNAILS AND TOENAILS
Indications & Usage
FOR DAMAGED AND THICKENED NAILS
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
WATER, PROPYLENE GLYCOL, TEA TREE OIL POLYSORBATE 20, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PROPYLPARABEN
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
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