Label: UREA- urea cream
- NDC Code(s): 58980-605-30
- Packager: Stratus Pharmaceuticals, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Updated April 22, 2010
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- SPL UNCLASSIFIED SECTION
For external use only.Close
Not for ophthalmic use.
UREA 10% CREAM is a potent keratolytic emollient which is a gentle tissue softener for skin and/or nails.
Each gram of UREA 10% CREAM contains 10% Urea in a cream base of Carbomer, Fragrance, Isopropyl Myristate, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearic Acid, Trolamine and Xanthan Gum.
- 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.Close
- 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.Close
Known hypersensitivity to any of the listed ingredients.Close
For external use only. Avoid contact with eyes, lips or mucous membranes.Close
If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
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, UREA 10% CREAM should be given to a pregnant woman only if clearly needed.
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 10% CREAM is administered to a nursing woman.
- ADVERSE REACTIONS
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.Close
- DOSAGE AND ADMINISTRATION
Apply UREA 10% CREAM to affected skin twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.Close
- HOW SUPPLIED
UREA 10% CREAM is supplied in:
85g (3 oz) tube 58980-605-30Close
- SPL UNCLASSIFIED SECTION
Sonar Products Inc.
Carlstadt, NJ 07072
Stratus Pharmaceuticals Inc
Miami, Florida 33186-6727
- PRINCIPAL DISPLAY PANEL - 85g Tube Carton
Net WT. 3 oz. (85g)
UREA 10% CREAM
Softens and Moisturizes Severe Dry Skin
Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58980-605 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea 8.5 g in 85 g Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-605-30 1 in 1 BOX 1 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/01/2010 Labeler - Stratus Pharmaceuticals, Inc (789001641) Establishment Name Address ID/FEI Business Operations Sonar Products, Inc 104283945 MANUFACTURE