Umecta Topical Suspension
Generic Name: urea
Dosage Form: topical suspension
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 Topical Suspension
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.
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.
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 Topical Suspension to affected skin twice per day or as directed by a physician. Rub in until completely absorbed.
How SuppliedUmecta® (urea, 40%) topical suspension supplied in a:
10 oz. bottle (topical suspension)
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