DERMASORB XM COMPLETE KIT- urea cream with moisturizing cream   
Crown Laboratories

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.

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DERMASORB XM COMPLETE KIT

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 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)

Revised: 11/2013
Document Id: 95e5f86e-897b-4ef9-a514-6b003387f84c
Set id: 95e5f86e-897b-4ef9-a514-6b003387f84c
Version: 1
Effective Time: 20131112
 
Crown Laboratories