1st Baron Verulam Dermasorb XM Generic Name: urea Dosage Form: cream with moisturizing cream kit Overview Side Effects Dosage Professional Reviews More Support Group Q & A Pricing & Coupons Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Dermasorb XM COMPLETE KIT Dermasorb XM Description 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: Slideshow Shingles: Settling The Score Dermasorb XM - 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. PHARMACOKINETICS The exact mechanism of action of topically applied urea is not known. 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. Contraindications Known hypersensitivity to any of the listed ingredients. Warnings For external use only. Avoid contact with eyes, lips or mucous membranes. Precautions 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. 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. 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. Adverse Reactions Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication. Dermasorb XM 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 CHILDREN How is Dermasorb XM 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 Rx Only P9471.00 Dermasorb XM Complete Kit p947400 Established Pharmacological Class Substance Pharmacological Class Dermasorb Extreme Moisturizer Lotions, Oils, Powders, and Creams Dermasorb XM COMPLETE KIT urea cream with moisturizing cream kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0316-1035 Packaging # Item Code Package Description 1 NDC:0316-1035-01 1 KIT 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 (UREA) UREA 390 mg in 1 g Inactive Ingredients Ingredient Name Strength DIMETHYL ISOSORBIDE POLAWAX POLYSORBATE GLYCERIN ISOPROPYL MYRISTATE WATER SORBITOL TRIDECYL STEARATE NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE TRIDECYL TRIMELLITATE Packaging # Item Code Package Description 1 NDC:0316-0204-01 1 BOTTLE, PLASTIC 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 Product Information Ingredients Ingredient Name Quantity WATER PETROLATUM GLYCERIN LIGHT MINERAL OIL CETYL ALCOHOL STEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER SODIUM P-CHLORO-M-CRESOL Packaging # Item Code Package Description 1 1 TUBE 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 Operations Crown Laboratories 079035945 manufacture(0316-1035) Revised: 11/2013 Crown Laboratories Next User Reviews Print this page Add to My Med List More about Dermasorb XM (urea topical) Side Effects Dosage Information Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: topical emollients Consumer resources Dermasorb XM Professional resources Urea Solution (FDA) Other brands: Latrix , Rea Lo 40 , X-Viate , Keralac , ... +22 more Other Formulations Dermasorb AF Dermasorb HC Related treatment guides Dermatological Disorders FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical emollients Related Drugs topical emollients Lac-Hydrin , Eucerin , ammonium lactate topical , glycerin topical , AmLactin , Aquaphor Dermatological Disorders triamcinolone , clobetasol topical , betamethasone , Temovate , Diprolene , Analpram-HC , Celestone , urea topical , Valisone , Clobex , Proctofoam HC , sodium hyaluronate topical , hydroquinone topical , Olux , Diprosone , Betamethacot , salicylic acid topical , Melamin , Diprolene AF , Celestone Soluspan , Analpram E , Clobevate , More... 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