Label: UREA 40 NAIL GEL- urea gel

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 9, 2021

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  • PRINCIPAL DISPLAY PANEL

    Label

    Urea

    FOR DAMAGED & THICKENED NAILS

    ANTI-FUNGAL

    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.

    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

    HYDROXYETHYL CELLULOSE NF, PURIFIED WATER, DIMETHYL SULFOXIDE USP

    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
    UREA 40 NAIL GEL 
    urea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA12 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    Product Characteristics
    Colorwhite (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81376-600-0130 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/07/2019
    Labeler - SSG Ventures Inc (047626115)
    Establishment
    NameAddressID/FEIBusiness Operations
    SSG Ventures Inc047626115manufacture(81376-600)
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