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Name:Umecta Urea
Manufacturer:Jsj Pharmaceuticals
Category:Prescription Marketed Drugs

Umecta Nail Film PI

UMECTA  UREA - urea film 
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.


Umecta Nail Film 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 40% Nail Film suspension with applicator and pen applicator contains urea (40%),
disodium EDTA, glycerin, hydroxyethylcellulose, PEG-6 caprylic/capric glycerides, purified water
and xanthan gum.

Image 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.


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.


Known hypersensitivity to any of the listed ingredients.


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


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.


Adverse Reactions

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

Dosage and Administration

Apply Umecta 40% Nail Film suspension to diseased or damaged nail tissue
or skin twice per day, or as directed by a physician. Cover with adhesive bandage
or gauze, secure with adhesive tape. An additional option is to remove
a “finger” from a plastic or vinyl glove and slip it over the bandage-covered
site. Secure glove finger with additional adhesive tape.

How Supplied

Umecta® 40% Nail Film (urea, 40%) suspension is available in a:

18 ml bottle - with applicator NDC 68712-010-01

Box of 6 - 3 ml - pen applicators NDC 68712-010-03

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

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Image of Carton

urea film
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68712-010
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  
Xanthan Gum  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:68712-010-01 18 g in 1 BOTTLE None
2 NDC:68712-010-03 6 DOSE PACK ( DOSE PACK) in 1 CARTON contains a DOSE PACK
2 3 g in 1 DOSE PACK This package is contained within the CARTON (68712-010-03)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2006

Labeler - JSJ Pharmaceuticals (615074866)
Name Address ID/FEI Operations
Harmony Labs 105803274 manufacture

Revised: 12/2010 JSJ Pharmaceuticals

Reproduced with permission of U.S. National Library of Medicine

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