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----------Umecta Topical Suspension 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® topical suspension contains 40% urea,
butylated hydroxytoluene, butyrospermum parkii fruit oil, disodium EDTA,
glyceryl stearate, glycine soja sterol, helianthus annuus oil, purified water, stearic
acid, sodium polyacrylate, and triethanolamine.
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 topical suspension to affected
skin twice per day or as directed by a physician. Rub in until completely
How SuppliedUmecta® (urea, 40%) topical suspension supplied in a:
10 oz. bottle (topical suspension)
Revised: 12/2010 JSJ Pharmaceuticals
Reproduced with permission of U.S. National Library of Medicine
Copyright © 2017
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