Label: UREA HYDRATING TOPICAL - urea aerosol, foam

  • NDC Code(s): 42192-115-15
  • Packager: Acella Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/10

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  • DESCRIPTION

    DESCRIPTION
    Urea 35% Hydrating Topical Foam is a keratolytic emollient in a water and lipid based foam containing lactic acid which is a gentle, but potent, tissue softener for skin and nails.
    Each gram of Urea 35% Hydrating Topical Foam contains Urea 35% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, lactic acid,
    methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, stearic acid, trolamine, and in propellants butane and propane.



    CHEMICAL STRUCTURE
    Urea has the following chemical structure:

    ureachemformula

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  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY
    Topically applied urea dissolves the intercellular matrix of the skin which results in enhanced shedding of scaly, dry skin and thus a softening of the hyperkeratotic areas of the skin.
    Urea topically applied to the nail plate has a similar effect on the intercellular matrix of the nail plate.

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  • PHARMACOKINETICS

    PHARMACOKINETICS
    The mechanism of action of topically applied urea is not yet known.

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  • INDICATIONS & USAGE

    INDICATIONS AND USAGE
    For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris,
    or eschar. Topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, and dry,
    rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails.

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  • CONTRAINDICATIONS

    CONTRAINDICATIONS
    Known hypersensitivity to any of the listed ingredients.

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  • WARNINGS

    WARNINGS
    Urea 35% Hydrating Topical Foam is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips, and all mucous membranes should be
    avoided. Urea 35% Hydrating Topical Foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.

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  • PRECAUTIONS

    PRECAUTIONS
    Urea 35% Hydrating Topical Foam should be used only as directed by a physician and should not be used to treat any condition other than that for which it is prescribed. If redness
    or irritation occurs, discontinue use and consult with a prescribing physician.

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  • PREGNANCY

    Pregnancy (Category B) – Animal reproduction studies have not been performed with topically applied urea and it is not known whether Urea 35% Hydrating Topical Foam can
    cause fetal harm when administered to a pregnant woman. Nevertheless, Urea 35% Hydrating Topical Foam should be used by a pregnant woman only if necessary.

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  • NURSING MOTHERS

    Nursing Mothers – It is not known whether topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be
    exercised by physicians when administering Urea 35% Hydrating Topical Foam to nursing mothers.

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  • ADVERSE REACTIONS

    ADVERSE REACTIONS
    Transient stinging, burning, itching or irritation is possible.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION
    Unless otherwise directed by a prescribing physician, Urea 35% Hydrating Topical Foam should be applied to affected area twice a day. Urea 35% Hydrating Topical Foam should
    be rubbed into the skin until it is completely absorbed.

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  • HOW SUPPLIED

    HOW SUPPLIED
    Urea 35% Hydrating Topical Foam is supplied in a 150 gram or 5.3 ounce aerosolized canister bearing the NDC Number 42192-115-15.

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  • SPL UNCLASSIFIED SECTION

    Enter section text here

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  • PRINCIPAL DISPLAY PANEL

    NDC 42192-115-15

    Urea 35% Hydrating
    Topical Foam

    Rx Only
    Net Wt. 5.3 oz. (150 g)


    NDC 42192-115-15
    Rx Only
    Net Wt. 5.3 oz. (150 g)
    Dosage and Administration: Clean and dry affected
    skin. Then apply Urea 35% Hydrating Topical Foam
    topically to cover affected skin twice per day, or as
    directed by a physician. Rub in until completely absorbed.
    Shake vigorously before each application and invert
    can to administer.

    Store at room temperature 59° - 77°F (15° - 25°C).
    See prescribing information for additional details.
    Ingredients: urea 35%, dimethicone, ethylparaben,
    glycerin, lactic acid, methylparaben, phenoxyethanol,
    polysorbate 20, povidone, propylene glycol, propylparaben,
    purified water, stearic acid, trolamine, and in
    propellants butane and propane.

    Warning: Contents under pressure. Do not puncture or
    incinerate. Do not expose to temperatures over 120°F
    (48°C) even when empty.

    Keep out of reach of children.

    Manufactured for:
    Acella Pharmaceuticals, LLC
    Alpharetta, GA 30009
    1-800-541-4802

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  • INGREDIENTS AND APPEARANCE
    UREA HYDRATING TOPICAL 
    urea aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42192-115
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UREA (UREA) UREA 35 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHICONE  
    ETHYLPARABEN  
    GLYCERIN  
    LACTIC ACID  
    METHYLPARABEN  
    PHENOXYETHANOL  
    POLYSORBATE 20  
    POVIDONE  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    STEARIC ACID  
    TROLAMINE  
    BUTANE  
    PROPANE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42192-115-15 150 g in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/09/2010
    Labeler - Acella Pharmaceuticals (825380939)
    Registrant - Acella Pharmaceuticals (825380939)
    Establishment
    Name Address ID/FEI Business Operations
    Acella Pharmaceuticlas 825380939 manufacture
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