Label: DERMASORB XM COMPLETE KIT- urea cream with moisturizing cream
- NDC Code(s): 0316-0204-01, 0316-1035-01
- Packager: Crown Laboratories
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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DERMASORB™XM (Urea 39%) Cream is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin. Each gram contains 390 mg Urea as the active ingredient and the following inactive ingredients: Dimethyl Isosorbide, Emulsifying Wax NF, Glycerin, Isopropyl Myristate, Purified Water, Sorbitol, Tridecyl Stearate and Neopentyl Glycol Dicaprylate/Dicaprate and Tridecyl Trimellitate.
Urea is diamide of carbonic acid with the following structure:
- CLINICAL PHARMACOLOGY
Urea cream 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.Close
The exact mechanism of action of topically applied urea is not known.Close
- INDICATION AND USAGE
DERMASORB™XM (Urea 39%) Cream is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.Close
Known hypersensitivity to any of the listed ingredients.Close
For external use only. Avoid contact with eyes, lips or mucous membranes.Close
Urea cream should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use.Close
- Pregnancy: Category C
Animal reproduction studies have not been conducted with urea cream. It is also not known whether urea cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Urea cream should be given to a pregnant woman only if clearly needed.Close
- Nursing Mothers
It is not known whether urea cream is excreted in human milk, therefore caution should be exercised when administering to a nursing mother.Close
- ADVERSE REACTIONS
Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication.Close
- DOSAGE AND ADMINISTRATION
Apply to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.
KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDRENClose
- HOW SUPPLIED
DERMASORB™XM (Urea 39%) Cream is supplied in:
227g NDC 0316-0204-01
Store at room temperature 15˚C - 30˚C (59˚F - 86˚F).
Protect from freezing.
Manufactured and distributed by: Crown Laboratories, Inc. Johnson City, TN 37604
- Dermasorb XM Complete Kit
- INGREDIENTS AND APPEARANCE
DERMASORB XM COMPLETE KIT
urea cream with moisturizing cream kit
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0316-1035 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-1035-01 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 227 g Part 2 1 TUBE 227 g Part 1 of 2 DERMASORB XM
39% urea cream cream
Product Information Item Code (Source) NDC:0316-0204 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 390 mg in 1 g Inactive Ingredients Ingredient Name Strength DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) POLAWAX POLYSORBATE (UNII: Q504PL8E0V) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TRIDECYL STEARATE (UNII: A8OE252M6L) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-0204-01 1 in 1 KIT 1 227 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/14/2013 Part 2 of 2 DERMASORB EXTREME MOISTURIZER
lotions, oils, powders, and creams
Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR PETROLATUM (UNII: 4T6H12BN9U) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR LIGHT MINERAL OIL (UNII: N6K5787QVP) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR STEARYL ALCOHOL (UNII: 2KR89I4H1Y) INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR SODIUM P-CHLORO-M-CRESOL (UNII: 343KVA8Y38) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 KIT 1 227 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/14/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/14/2013 Labeler - Crown Laboratories (079035945) Registrant - Crown Laboratories (079035945) Establishment Name Address ID/FEI Business Operations Crown Laboratories 079035945 manufacture(0316-1035)