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----------Umecta Nail Film PI
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.
Indications and Uses
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly
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,
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
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing
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.
Revised: 12/2010 JSJ Pharmaceuticals
Reproduced with permission of U.S. National Library of Medicine
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