Umecta Urea

UMECTA UREA- urea suspension
Innocutis Holdings, 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.

Description


Rx only
For topical use only
Not for ophthalmic use
Umecta is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and skin
Each gram of Umecta® topical suspension contains 40% urea, butylated hydroxytoluene, butyrospermum parkii fruit oil, disodium EDTA, glyceryl stearate, glycine soja sterol, helianthus annuus oil, purified water, stearic
acid, sodium polyacrylate, and triethanolamine.
Image of chemical structureImage of chemical structure

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 purulent 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 Category C

Animal reproduction studies have not been conducted with Umecta. It is also not known whether Umecta can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Umecta 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 Umecta is administered to a nursing woman.

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

Adverse Reactions to Umecta Urea

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

Dosage and Administration

Apply Umecta topical suspension to affected skin twice per day or as directed by a physician. Rub in until completely absorbed.

How Supplied

Umecta® (urea, 40%) topical suspension supplied in a:

10 oz. bottle (topical suspension)

NDC 68712-005-01

Manufactured for:

Innocutis Holdings, LLC.
Charleston, SC 29401
Toll Free: 1-800-499-4468
www.innocutis.com
www.umecta.com

Label
(click image for full-size original)
UMECTA UREA urea suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68712-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 400 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SHEA BUTTER
BUTYLATED HYDROXYTOLUENE
SOYBEAN OIL
SUNFLOWER OIL
GLYCERYL MONOSTEARATE
WATER
STEARIC ACID
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68712-005-01 283.4 g in 1 TUBE None
2 NDC:68712-005-02 3 g in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2004
Labeler — Innocutis Holdings, LLC (071501252)
Establishment
Name Address ID/FEI Operations
Ei Inc. 105803274 manufacture

Revised: 11/2011 Innocutis Holdings, LLC


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