URE-39 (UREA) CREAM [SOLUTECH PHARMACEUTICALS LLC]

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URE-39 (UREA) CREAM [SOLUTECH PHARMACEUTICALS LLC]
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NDC 70350-2612-1
Set ID ecf5d277-b1f6-495f-9f08-204217bef84e
Category HUMAN PRESCRIPTION DRUG LABEL
Packager SOLUTECH PHARMACEUTICALS LLC
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    Rx only

    For external use only.

    Not for ophthalmic use.

  • URE-39 Description

    URE-39 Cream is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.

    Each gram of URE-39 Cream contains:

    ACTIVE: 39% Urea in a cream base of:

    INACTIVES: Deionized Water, Carthamus Tinctorius (Safflower) Seed Oil, Emulsifying Wax, Glycerine, Propylene Glycol, Glyceryl Stearate, PEG 100 Stearate, Cetyl Alcohol, Dimethicone, C12/15 Alkyl Benzoate, Anthemis Nobilis (Chamomile) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, and Isobutylparaben.

    CHEMISTRY

    Urea is a diamide of carbonic acid with the following chemical structure:

    Chemical Structure

  • URE-39 - 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. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

    PHARMACOKINETICS

    The mechanism of action of topically applied Urea is not yet known.

  • INDICATIONS AND USES

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

  • Contraindications

    URE-39 Cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients.

  • Warnings

    For external use only. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin.

  • Precautions

    Stop use and ask a doctor if redness or irritation develops. After applying this medication, wash hands and unaffected areas thoroughly. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

    PREGNANCY

    Pregnancy Category B

    Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, URE-39 Cream should be given to a pregnant woman only if clearly needed.

    NURSING MOTHERS

    It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when URE-39 Cream is administered to a nursing woman.

  • Adverse Reactions

    Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

  • URE-39 - Dosage and Administration

    Apply URE-39 Cream to affected skin two to three times per day as needed or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue two to three times per day or as directed by a physician. Best applied to affected areas immediately after showering and just before bedtime.

  • How is URE-39 Supplied

    URE-39 (39% Urea Cream) is supplied in:

    8oz (227gm) JarNDC: 70350-2612-1

    Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). Protect from freezing. [See USP Controlled Room Temperature.]

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Solutech Pharmaceuticals LLC
    Peoria, AZ 85345

    Rx only

  • PRINCIPAL DISPLAY PANEL - 227 gm Jar Label

    NDC 70350-2612-1

    FOR TOPICAL USE ONLY

    URE-39
    UREA 39% CREAM

    Smooth Easily Spreadable

    Rx only

    Solutech
    PHARMACEUTICALS

    Net WT.
    8OZ (227 gm)

    PRINCIPAL DISPLAY PANEL - 227 gm Jar Label
  • INGREDIENTS AND APPEARANCE
    URE-39 
    urea cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70350-2612
    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
    WATER (UNII: 059QF0KO0R)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70350-2612-1227 g in 1 JAR; Type 0: Not a Combination Product09/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER09/01/2017
    Labeler - SOLUTECH PHARMACEUTICALS LLC (080040396)
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