Label: UREA 20- urea gel

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

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Drug Label Information

Updated April 7, 2021

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  • PRINCIPAL DISPLAY PANEL

    Label

    Inactive Ingredients

    PRESERVED WATER, MINERAL OIL, PROPYLENE GLYCOL, TRIETHANOLAMINE, COCONUT OIL, EMULTHIX, CARBOMER, XANTHAN GUM, TEA TREE OIL, ALOE VERA, METHYLPARABEN, PROPYLPARABEN

    Inactive Ingredients

    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 20%

    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

    KEEP OUT OF REACH OF CHILDREN.

    UREA

    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.

  • INGREDIENTS AND APPEARANCE
    UREA 20 
    urea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    Colorwhite (Opaque White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81376-210-08113 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/20/2019
    Labeler - SSG Ventures Inc (047626115)
    Establishment
    NameAddressID/FEIBusiness Operations
    SSG Ventures Inc047626115manufacture(81376-210)
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