Label: UREA cream

  • NDC Code(s): 42792-101-08
  • Packager: AUSTIN PHARMACEUTICALS, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 11, 2018

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  • SPL UNCLASSIFIED SECTION

  • DESCRIPTION:

    This product is a keratolytic, emollient which is a gentle, yet potent, tissue softener for skin.

    Each gram contains 390 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, sodium hydroxide, water, and xanthan gum.

    Urea is a diamide of carbonic acid with the following chemical structure:

    structure

  • CLINICAL PHARMACOLOGY:

  • INDICATIONS:

  • CONTRAINDICATIONS:

  • WARNING:

    KEEP OUT OF REACH OF CHILDREN.

  • PRECAUTIONS:

  • ADVERSE REACTIONS:

  • DOSAGE AND ADMINISTRATION:

  • STORAGE:

  • HOW SUPPLIED:

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    UREA 
    urea cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42792-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA390 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42792-101-08227 g in 1 BOTTLE; Type 0: Not a Combination Product03/09/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/09/2011
    Labeler - AUSTIN PHARMACEUTICALS, LLC (078398514)