Label: UREA- urea cream 

  • Label RSS
  • NDC Code(s): 58980-610-30
  • Packager: Stratus Pharamceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/09

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Urea 20%

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  • Purpose

    Keratolytic

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  • Inactive Ingredients

    Carbomer, Fragrance, Isopropyl Myristate, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearic Acid, Trolamine and Xanthan Gum.

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  • Warnings

    FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin. Do not use if known hypersensitivity to any of the listed ingredients.

    Precautions

    Stop use and ask a doctor if redness or irritation develops. Keep this and all other medications out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Pregnancy

    If pregnant or breast feeding, ask a health professional before use.

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  • Directions

    Apply to the affected areas twice a day or as directed by a physician. Rub into the skin until completely absorbed.

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  • STORAGE AND HANDLING

    Store at controlled room temperature 15° - 30°C (59° - 86°F). Protect from Freezing. SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION. See Crimp and end of carton for Lot Number and Expiration Date.

    UC20(3)-200907

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  • PRINCIPAL DISPLAY PANEL - 85 g Label

    NDC 58980-610-30
    Net WT. 3 oz. (85g)

    UREA 20% CREAM
    STRATUS

    PHARMACEUTICALS INC

    Softens and Moisturizes Severe Dry Skin

    Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

    Principal Display Panel - 85 g Label
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  • INGREDIENTS AND APPEARANCE
    UREA 
    urea cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58980-610
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Urea (Urea) Urea 17 g  in 85 g
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-610-30 1 in 1 BOX
    1 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved other 10/31/2008
    Labeler - Stratus Pharamceuticals, Inc (789001641)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products, Inc 104283945 MANUFACTURE
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