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Umecta Nail Film

Generic Name: urea
Dosage Form: topical film

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

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 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.




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 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.

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:

Innocutis Holdings LLC
Charleston, SC 29401
Toll Free: 1-800-499-4468
www.innocutis.com
www.umecta.com









UMECTA   UREA
urea film
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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  
Glycerin  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES  
Water  
Xanthan Gum  
Packaging
# Item Code Package Description
1 NDC:68712-010-01 18 g in 1 BOTTLE
2 NDC:68712-010-03 6 DOSE PACK (DOSE PACK) in 1 CARTON
2 3 g in 1 DOSE PACK
3 NDC:68712-010-04 18 DOSE PACK (DOSE PACK) in 1 CARTON
3 3 g in 1 DOSE PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2006
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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