Umecta Topical Suspension

Name: Umecta Topical Suspension

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.

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.

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





UMECTA   UREA
urea suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:68712-005-01 283.4 g in 1 TUBE
2 NDC:68712-005-02 3 g in 1 PACKET
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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