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.
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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.
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.
ContraindicationsKnown hypersensitivity to any of the listed ingredients.
For external use only. Avoid contact with eyes, lips or mucous membranes.
PrecautionsThis 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 CAnimal 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.
Dosage and AdministrationApply 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 SuppliedUmecta® 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.
Innocutis Holdings LLC
Charleston, SC 29401
Toll Free: 1-800-499-4468
|Labeler - Innocutis Holdings LLC (071501252)|
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- Drug class: topical emollients