Label: UREA 39.5% WITH 2% SALICYLIC ACID- urea, salicylic acid cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 24, 2023

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  • DESCRIPTION

    Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space. Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of: Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid.

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

    Chemical Structure

  • CLINICAL PHARMACOLOGY

    Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.

    Pharmacokinetics

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

  • INDICATIONS & USAGE

    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 eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

  • 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.When using this product skin irritation and dryness is more likely to occur.

    General

    This product 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 and consult a physician.

    Information for Patients

    Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

    Carcinogenesis, Mutagenesis and Impairment of Fertility:

    Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.

    Pregnancy:

    Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

    Nursing Mothers:

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

  • ADVERSE REACTIONS:

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

  • DOSAGE AND ADMINISTRATION

    Apply Urea 39.5% Cream with 2% Salicylic Acid to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.
    Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

  • HOW SUPPLIED

    Urea 39.5% Cream with 2% Salicylic Acid 8 oz. (227 g): NDC 59088-210-16

  • STORAGE

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

  • Urea 39.5% Cream™ with 2% Salicylic Acid

    Manufactured in the USA by:
    PureTek Corporation
    Panorama City, CA 91402
    For questions or information
    call toll-free: 877-921-7873

    Label

  • INGREDIENTS AND APPEARANCE
    UREA 39.5% WITH 2% SALICYLIC ACID 
    urea, salicylic acid cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA39.5 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-210-16227 g in 1 JAR; Type 0: Not a Combination Product03/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/24/2023
    Labeler - PureTek Corporation (785961046)
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