Label: UREA- 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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  • 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

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  • CLINICAL PHARMACOLOGY:
  • INDICATIONS:
  • CONTRAINDICATIONS:
  • WARNING:

    KEEP OUT OF REACH OF CHILDREN.

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  • PRECAUTIONS:
  • ADVERSE REACTIONS:
  • DOSAGE AND ADMINISTRATION:
  • STORAGE:
  • HOW SUPPLIED:
  • INGREDIENTS AND APPEARANCE
    UREA 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42792-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 390 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42792-101-08 227 g in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/09/2011
    Labeler - AUSTIN PHARMACEUTICALS, LLC (078398514)
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