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Name:Umecta Mousseurea 40%
Manufacturer:Jsj Pharmaceuticals
Category:Prescription Marketed Drugs


Umecta Mousse PI

UMECTA MOUSSE UREA 40% - urea aerosol, foam 
JSJ Pharmaceuticals

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.

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Umecta Mousse PI

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 mousse contains urea (40%), Butane, Butyrospermum Parkii
(Shea Butter) Extract, Carbomer, Glycine Soya (Soy Bean) Sterol, Helianthus Annuus
(Sunflower) Oil, Isobutane, Laureth-4, Polysorbate-20, Propane, Purified Water,
Stearic Acid, Triethanolamine. Urea is a diamide of carbonic acid with the
following chemical structure:




Image of chemical Structure



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.

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

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.

Known hypersensitivity to any of the listed ingredients.

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

Umecta Mousse canister - contents under pressure do not puncture or
incinerate. Do not store at temperatures above 120º F.

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.

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.

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.

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

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

Umecta (urea, 40%) mousse is available in a:

4 oz. can NDC 68712-020-01

Store at controlled room temperature 15-30°C (59-86°F).

Protect from freezing.

Manufactured for:

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


Image of carton



Image of label


UMECTA MOUSSE  UREA 40%
urea foam aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68712-020
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
BUTANE  
SHEA BUTTER  
CARBOMER 934  
SOYBEAN OIL  
SUNFLOWER OIL  
ISOBUTANE  
LAURETH-4  
POLYSORBATE 20  
PROPANE  
WATER  
STEARIC ACID  
TROLAMINE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68712-020-01 113.4 g in 1 CAN None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2007

Labeler - JSJ Pharmaceuticals (615074866)
Establishment
Name Address ID/FEI Operations
Sonar Products 104283945 manufacture

Revised: 08/2009 JSJ Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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