UREA CREAM 40%- urea cream

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Major Pharmaceuticals

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 eshar. 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, as well as damaged, ingrown and devitalized nails. Contraindications Known hypersensitivity to any of the listed ingredients.

Ապրանքի ամփոփագիր:

How Supplied Urea 40% Cream 1 oz.(28.35 g): NDC 0904-7167-23; Urea 40% Cream 3 oz.(85 g): NDC 0904-7167-83; Urea 40% Cream 7 oz.(198.4 g): NDC 0904-7167-99. Store at room temperature 15°C - 30°C (59°F - 86°F). Protect from freezing. Keep bottle tightly closed.

Լիազորման կարգավիճակը:

unapproved drug other

Ապրանքի հատկությունները

UREA CREAM 40%- UREA CREAM
MAJOR 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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UREA CREAM 40%
UREA 40%
Rx Only
For topical use only.
Not for ophthalmic use.
DESCRIPTION
Urea 40% is a keratolytic emollient which is a gentle, yet potent,
tissue softener for nails
and/or skin. Each gram of Urea 40% contains 40% urea as an active
ingredient, and the
following inactive ingredients: Ceteareth-6, Ceteareth-25, Cetyl
Alcohol, Mineral Oil,
Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol,
Xanthan Gum.
Urea is a diamide of carbonic acid with the following chemical
structure:
CLINICAL PHARMACOLOGY
Urea gently dissolves the intracellular matrix which results in
loosening of the horny
layer of the skin and shedding of scaly skin at regular intervals,
thereby softening
hyperkeratotic areas of the skin.
PHARMACOKINETICS
The mechanism of action of 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 eshar. 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, as well
as damaged,
ingrown and devitalized nails.
CONTRAINDICATIONS
Known hypersensitivity to any of the listed ingredients.
WARNINGS
For topical 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 and consult a physician.
PREGNANACY
Pregnancy Category B. Animal reproduction studies have revealed no
evidence of harm
to the