UREA CREAM 40%- urea cream

Urea Cream 40% by

Drug Labeling and Warnings

Urea Cream 40% by is a Prescription medication manufactured, distributed, or labeled by Laser Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Urea Cream 40%

Rx Only     For external use only.     Not for ophthalmic use.

DESCRIPTION

Description

Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin.  Each gram of Urea 40% contains 40% urea as an active ingredient, and the following inactive ingredients:  Carbomer, Dimethyl Isosorbide, Emulsifying Wax, Glycerin, Isopropyl Myristate, Neopentyl Glycol Dicaprylate/Dicaprate, Purified Water, Sodium Hydroxide, Tridecyl Stearate, Tridecyl Trimellilate, and Xanthan Gum.

Urea is a diamide of carbonic acid with the following chemical structure:

CLINICAL PHARMACOLOGY

Clinical Pharmacology

Urea 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

Pharmacokinetics

The mechanism of action of topically applied urea is not yet known.

INDICATIONS & USAGE

Indications and Usage

For debridement and promotion of healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar.  Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

CONTRAINDICATIONS

Contraindications

Known hypersensitivity to any of the listed ingredients.

WARNINGS

Warnings

For topical use only.  Avoid contact with eyes, lips or mucous membranes.

PRECAUTIONS

Precautions

This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed.  If redness or irritation occurs, discontinue use and consult a physician.

PREGNANCY

PREGNANACY

Pregnancy Category B.  Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women.  Because animal reproductive studies are not always predictive of human response, Urea 40% should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

NURSING MOTHERS

It is not known whether or not this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when Urea 40% is administered to a nursing woman.

ADVERSE REACTIONS

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.

DOSAGE & ADMINISTRATION

Dosage and Administration

Apply Urea 40% to affected skin twice a day, or as directed by your physician.  Rub in until completely absorbed.

Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.  Please note:  this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing.  No representation is made as to generic status or bioequivalency.  Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluation of the active ingredients, excipients, inactive ingredients and chemical information provided herein.

HOW SUPPLIED

How Supplied

Urea 40% Cream 1 oz.(28.35 g):  NDC: 16477-340-01; Urea 40% Cream 3 oz.(85 g):  NDC: 16477-340-03; Urea 40% Cream 7 oz.(198.4 g):  NDC: 16477-340-07

STORAGE AND HANDLING

Store at room temperature 15 οC - 30 οC (59 οF - 86 ο F).  Protect from freezing.  Keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UREA CREAM 40% 
urea cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 16477-340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSORBIDE (UNII: WXR179L51S)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIDECYL STEARATE (UNII: A8OE252M6L)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16477-340-03	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2018
2	NDC: 16477-340-07	198.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2018
3	NDC: 16477-340-01	28.35 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/04/2018

Labeler - Laser Pharmaceuticals, LLC (614417132)