Your browser does not support JavaScript! DERMASORB XM COMPLETE KIT (UREA CREAM WITH MOISTURIZING CREAM) KIT [CROWN LABORATORIES]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

DERMASORB XM COMPLETE KIT (urea cream with moisturizing cream) kit
[Crown Laboratories]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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:

Urea 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.

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.

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 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

Dermasorb XM Trade Carton

DERMASORB XM COMPLETE KIT 
urea cream with moisturizing cream kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0316-1035
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-1035-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 227 g
Part 21 TUBE 227 g
Part 1 of 2
DERMASORB XM 
39% urea cream cream
Product Information
Item Code (Source)NDC:0316-0204
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UREA) UREA390 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIMETHYL ISOSORBIDE 
POLAWAX POLYSORBATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
WATER 
SORBITOL 
TRIDECYL STEARATE 
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE 
TRIDECYL TRIMELLITATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-0204-011 in 1 KIT
1227 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/14/2013
Part 2 of 2
DERMASORB EXTREME MOISTURIZER 
lotions, oils, powders, and creams
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRPETROLATUM 
INGRGLYCERIN 
INGRLIGHT MINERAL OIL 
INGRCETYL ALCOHOL 
INGRSTEARYL ALCOHOL 
INGRPOLYOXYL 20 CETOSTEARYL ETHER 
INGRSODIUM P-CHLORO-M-CRESOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 KIT
1227 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/14/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/14/2013
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-1035)

Revised: 11/2013
 
Crown Laboratories

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services