UREA GEL [EXACT-RX, INC.]

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UREA GEL [EXACT-RX, INC.]
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NDC 42808-204-28
Set ID b58e175d-60e8-4206-ac7a-c67b68ac80f0
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Exact-Rx, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    For external use only. Not for ophthalmic use.
    Keep away from eyes, lips and mucous membranes.

  • DESCRIPTION

    DESCRIPTION: UREA Nail Gel 45% is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of UREA Nail Gel 45% contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water.

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

    Structure
  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY: Urea gently dissolves the intracellular 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

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

  • INDICATIONS & USAGE

    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 purulent 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 and ingrown nails.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

  • WARNINGS

    WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes.

  • PRECAUTIONS

    PRECAUTIONS: This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

    PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea Nail Gel 45% 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 Urea Nail Gel 45% is administered to a nursing woman.

  • ADVERSE REACTIONS

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

    Call your doctor for medical advice about side effects.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Apply Urea Nail Gel 45% to diseased or damaged nail tissue twice per day, or as directed by a physician.

  • INSTRUCTIONS FOR USE

    DIRECTIONS FOR SKIN: Apply Urea Nail Gel 45% to affected area(s) twice per day, or as directed by a physician. Rub in until gel is absorbed.

  • HOW SUPPLIED:

    Urea Nail Gel 45% is supplied in a 28 mL glass bottle NDC 42808-0204-28.

    Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing.

    Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

    00-0204-28-205-00

    Iss:7/11

  • PRINCIPAL DISPLAY PANEL

    For External Use Only

    NDC 42808-0204-28        Rx Only

    Urea
    In a vehicle containing
    menthol, camphor &
    eucalyptus oil

    45%

    NAIL GEL

    Exact-Rx.
    INCORPORATED

    Net Wt. 28 mL

    Carton

  • INGREDIENTS AND APPEARANCE
    UREA 
    urea gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42808-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA450 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42808-204-281 in 1 CARTON08/01/2011
    128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2011
    Labeler - Exact-Rx, Inc. (137953498)
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