Dermasorb XM Complete Kit

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.

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
(click image for full-size original)

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
(click image for full-size original)
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 Item Code (Source) NDC:0316-1035
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0316-1035-01 1 KIT in 1 KIT None
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 Multilevel Packaging
1 NDC:0316-0204-01 1 BOTTLE, PLASTIC in 1 KIT contains a BOTTLE, PLASTIC
1 227 g in 1 BOTTLE, PLASTIC This package is contained within the KIT (0316-0204-01)
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 Multilevel Packaging
1 1 TUBE in 1 KIT contains a TUBE
1 227 g in 1 TUBE This package is contained within the KIT
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

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