UREVAZ

UREVAZ- urea cream
Sterling Knight Pharmaceuticals, LLC

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.

UREVAZ Urea Cream 44%

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Rx Only

DESCRIPTION

Urea, 44 % is a keratolytic emollient which is gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea Cream, 44 % contains 44% urea, edetate disodium dihydrate, glycerin, hydroxethylcellulose, PEG-6 caprylic/capric glyceride, purified water,phenoxyethanol,ethylexylglycerin and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure:

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CLINICAL PHARMACOLOGY

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

Pharmacokinetics

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

INDICATIONS AND USES

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

CONTRAINDICATIONS

Known hypersensitivity to any of the listed ingredients.

WARNINGS

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

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.

Pregnancy

Pregnancy category C

Animal reproduction studies have not been conducted with urea 44%. It also is not known whether urea 44% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urea 44% should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea 44% is administered to a nursing woman.

ADVERSE REACTIONS

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

DOSAGE AND ADMINISTRATION

Apply Urea 44% to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day, or as directed by a physician.

HOW SUPPLIED

Urea Cream, 44% is available as follows:

60 g tube (NDC 69336-801-60)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

Manufactured for:

Sterling Knight Pharmaceuticals, LLC

Ripley, MS 38663

Rx Only

Sterling Knight Pharmaceuticals, LLC

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — CARTON

Urea Cream, 44 %

For External Use Only. Not for Ophthalmic Use.

Rx Only

urevaz
(click image for full-size original)
UREVAZ
urea cream 44% cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69336-801
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 440 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES
GLYCERIN
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
XANTHAN GUM
EDETATE DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69336-801-60 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (69336-801-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/21/2015
Labeler — Sterling Knight Pharmaceuticals, LLC (079556942)

Revised: 05/2015 Sterling Knight Pharmaceuticals, LLC

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