Active Ingredients:
UREA, TEA TREE OIL, ALOE VERA
Urea 40
FDA Label NDC 81376-211
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 Urea 40 (NDC 81376-211). 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, active ingredients:, otc - purpose, indications & usage, safe handling warning, otc - keep out of reach of children, instructions for use, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
SOOTHES ROUGH & DRY SKIN
HEALS CORNS & CALLOUSES
Indications & Usage
SOOTHES ROUGH & DRY SKIN
Safe Handling Warning
FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.
KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.
KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Instructions For Use
APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.
Inactive Ingredient
CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE GLYCOL,TRIETHANOLAMINE, EMULSIFIERS, COCONUT OIL, PRESERVED WATER
Storage And Handling
KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.
Other Safety Information
ENHANCED WITH TEA TREE OIL & ALOE VERA
Dosage & Administration
APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.
Warnings
FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.
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