Your browser does not support JavaScript! UREA CREAM UREA LOTION [ASCEND LABORATORIES, LLC]
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RxNorm Names

UREA cream
UREA lotion
[Ascend Laboratories, LLC]


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


UreaHeader

RX ONLY

DESCRIPTION
Urea cream, 40% is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin.

Each gram contains 40% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax NF, glycerin 99.7% USP, isopropyl myristate, purified water, sorbitol 70% Solution USP, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate.

CHEMICAL STRUCTURE
Urea is diamide of Carbonic acid with the following structure:

ChemicalStructure

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
Urea 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 ADMINISTRATIONS
Apply to affected skin twice per day, or as directeded by your physician. Rub in until completely absorbed.

KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN

HOW SUPPLIED
Urea 40% cream is supplied in
28.35gm               NDC 67877-272-21
85.05gm               NDC 67877-272-03
198.6gm               NDC 67877-272-07

Urea 40% lotion is supplied in
236.6ml               NDC 67877-273-12

Store at room temperature 15°C -30°C (59°F-86°F).
Protect from freezing.

Manufactured for:                                           Manufactured by:
Ascend Laboratories, LLC                  Crown Laboratories, Inc
Montvale, NJ 07645                                       Johnson City, TN 37604


P1827.01


PACKAGE LABEL - Urea Cream 40%

ASCEND

Laboratories, LLC

NDC 67877-272-21

Urea
Cream
40%


For Topical Use
Only

Rx Only

NET WT 1 oz
(28.35g)

CreamProductLabel


PACKAGE LABEL - Urea Lotion 40%

ASCEND
Laboratories, LLC

NDC 67877-273-12

Urea
Lotion
40%

For Topical Use
Only

Rx Only

8 fl oz
(236.6ml)

LotionProductLabel
UREA 
urea cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:67877-272
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (Urea) Urea400 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIMETHYL ISOSORBIDE 
GLYCERIN 
ISOPROPYL MYRISTATE 
WATER 
SORBITOL700 mg  in 1 g
TRIDECYL STEARATE 
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE 
TRIDECYL TRIMELLITATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67877-272-2128.35 g in 1 TUBE
2NDC:67877-272-0385.05 g in 1 TUBE
3NDC:67877-272-07198.6 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/16/2012
UREA 
urea lotion
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:67877-273
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (Urea) Urea400 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYL ISOSORBIDE 
GLYCERIN 
ISOPROPYL MYRISTATE 
WATER 
SORBITOL700 mg  in 1 mL
TRIDECYL STEARATE 
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE 
TRIDECYL TRIMELLITATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67877-273-12236.6 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/16/2012
Labeler - Ascend Laboratories, LLC (141250469)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories, Inc.079035945manufacture

Revised: 3/2012
 
Ascend Laboratories, LLC

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