UREA CREAM [AUSTIN PHARMACEUTICALS, LLC]

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UREA CREAM [AUSTIN PHARMACEUTICALS, LLC]
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NDC 42792-101-08
Set ID 479ed619-f22e-4fa6-bbc5-c612f6e94ac8
Category HUMAN PRESCRIPTION DRUG LABEL
Packager AUSTIN PHARMACEUTICALS, LLC
Generic Name
Product Class
Product Number
Application Number
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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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories, Inc. 002290302manufacture(42792-101) , label(42792-101) , analysis(42792-101) , pack(42792-101)
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