Label: UREA 40 PERCENT- urea cream

  • 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 24, 2024

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  • DESCRIPTION:
    INGREDIENTS: Each gram - of Urea Cream 40% contains Urea 40% and the - following inactive - ingredients: Carbomer, Cetearyl Alcohol, Glycerin, Glyceryl Stearate SE ...
  • CLINICAL PHARMACOLOGY:
    Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas of the ...
  • INDICATIONS:
    This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses ...
  • CONTRAINDICATIONS:
    This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
  • WARNINGS:
    FOREXTERNALUSEONLY.NOTFOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes. General: This product is to be used as directed by a physician ...
  • ADVERSE REACTIONS:
    Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
  • DOSAGE AND ADMINISTRATION:
    Use as - directed by your physician. See label booklet for full - Prescribing Information.
  • STORAGE:
    Store at room - temperature 15°C-30°C - (59°F-86°F). Protect from freezing. Keep bottle tightly closed.
  • HOW SUPPLIED:
    This product is supplied in the following size: NDC 72162-1668-2: 7 oz (198.4 g) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
  • PRINCIPAL DISPLAY PANEL
    Urea Cream 40%
  • INGREDIENTS AND APPEARANCE
    Product Information