Umecta Emulsion

Name: Umecta Emulsion

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.





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.

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.

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
Share
(web3)