Package Label.Principal Display Panel
Single Label- Urea 20
Urea 20
FDA Label NDC 81376-210
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 20 (NDC 81376-210). 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, inactive ingredients, directions, active ingredients, directions:, indications:, otc - keep out of reach of children, otc - active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
TEA TREE OIL, ALOE VERA, CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE GLYCOL,TRIETHANOLAMINE, EMULSIFIERS, COCONUT OIL, PRESERVED WATER
CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE
GLYCOL, EMULSIFIERS, TRIETHANOLOAMINE
Directions
APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR
AS NEEDED. USE CONTINUOUSLY FOR 2-3 WEEKS FOR
OPTIMAL RESULTS.
Active Ingredients
UREA, TEA TREE OIL, ALOE VERA
Directions:
APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.
Indications:
SOOTHES ROUGH & DRY SKINSOFTEN NAILSMOISTURIZING GEL
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Otc - Active Ingredient
UREA
Otc - Purpose
REDUCES CORNS & CALLUSES
Safety Warning :
FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.
* Please review the disclaimer below.
