UREA emulsion

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)

Tersedia dari:

ACELLA PHARMACEUTICALS

INN (Nama Internasional):

UREA

Komposisi:

UREA 50 g in 100 g

Rute administrasi :

TOPICAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

INDICATIONS AND USAGE: 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 pilaris, keratosis palmaris, keratoderma, corns and calluses. CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

Ringkasan produk:

HOW SUPPLIED: 50% Urea Emulsion is supplied in a 10 oz. tube (NDC 42192-101-10). Store at controlled room temperature, 15° - 30° (59° - 86°F). Protect from freezing.

Status otorisasi:

unapproved drug other

Karakteristik produk

UREA- UREA EMULSION
ACELLA PHARMACEUTICALS
_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._
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50% UREA EMULSION
DESCRIPTION: Each gram of 50% Urea Emulsion contains 50% urea in a
formulation consisting of:
caprylic/capric triglyceride, cetyl alcohol, disodium EDTA, glycerin,
hydroxyethyl cellulose, lactic
acid, linoleic acid, PEG-6, polysorbate 60, propylene glycol, sorbitan
stearate, titanium dioxide,
triethanolamine, purified water, vitamin E, xanthan gum and zinc
undecylenate.
Urea is a diamide of carbonic acid with the following chemical
structure:
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.
PHARMACOKINETICS: The mechanism of action of the topically applied
Urea is not yet known.
INDICATIONS AND USAGE: 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 pilaris, keratosis palmaris,
keratoderma, corns and calluses.
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: Pregnancy Category B. Animal reproduction studies have
revealed no evidence of harm
to the fetus; however, there are no adequate and well-controlled
studies in pregnant women. Because
animal reproduction studies are not always pre