UREA CREAM 40%- urea cream

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Akron Pharma Inc.

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

How Supplied Urea 40% Cream 1 oz.(28.35 g): NDC 71399-8456-1; Urea 40% Cream 3 oz.(85 g): NDC NDC 71399-8456-3; Urea 40% Cream 7 oz.(198.45 g): NDC NDC 71399-8456-7  Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing and excessive heat. Keep bottle tightly closed. Manufactured for: Akron Pharma Inc., Fairfield, NJ-07004 www.akronpharma.com Manufactured In USA

מצב אישור:

unapproved drug other

מאפייני מוצר

UREA CREAM 40%- UREA CREAM
AKRON PHARMA INC.
_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
Each gram contains 400 mg of urea in a vehicle consisting of:
cetyl alcohol, glycerin monostearate, phosphomer X-polymer, mineral
oil, propylene
glycol, purified water, trolamine 99%, white petrolatum, xanthan gum.
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.
KEEP OUT OF REACH OF CHILDREN.
PRECAUTIONS
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous
membranes.
PREGNANACY
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 reproductive studies are not always predictive
of human
response, Urea 40% should be given to a pregnant woman only if clearly
needed.
NURSING MOTHERS
It is not known whether or not this drug is excreted