Label: CLEAR 50 NAIL GEL- urea gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 27, 2021

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  • PRINCIPAL DISPLAY PANEL

    Label

    Urea 50%

    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

    FOR DAMAGED AND THICKENED NAILS

    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

    WATER, PROPYLENE GLYCOL, TEA TREE OIL POLYSORBATE 20, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PROPYLPARABEN

    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

  • INGREDIENTS AND APPEARANCE
    CLEAR 50 NAIL GEL 
    urea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-611
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA50 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81376-611-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2021
    Labeler - SSG Ventures Inc (047626115)
    Establishment
    NameAddressID/FEIBusiness Operations
    SSG Ventures Inc047626115manufacture(81376-611)
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