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Umecta Emulsion

Generic Name: urea
Dosage Form: topical emulsion

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.

Umecta Mousse PI

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® emulsion and 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.





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.

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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 Monthers

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

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

Dosage and Administration

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

How Supplied

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

4 oz. plastic tube (emulsion)
NDC 68712-004-03

8 oz. plastic tube (emulsion)
NDC 68712-004-01

Manufactured for:

JSJ Pharmaceuticals
Charleston, SC 29401
Toll Free: 1-800-499-4468
www.jsjpharm.com
www.umecta.com





UMECTA   UREA
urea emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68712-004
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
1 NDC:68712-004-01 227 g in 1 TUBE
2 NDC:68712-004-02 3 g in 1 PACKET
3 NDC:68712-004-03 120 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2004
Labeler - JSJ Pharmaceuticals (615074866)
Establishment
Name Address ID/FEI Operations
Harmony Labs 105803274 manufacture
Revised: 12/2010
 
JSJ Pharmaceuticals
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