UREA cream

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

BioComp Pharma, Inc.

INN (Միջազգային անվանումը):

UREA

Կազմը:

UREA 400 mg in 1 g

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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, as well as damaged, ingrown and devitalized nails. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

Ապրանքի ամփոփագիր:

1 oz. (28.35 g) bottles, NDC 44523-617-01 3 oz. (85 g) bottles, NDC 44523-617-03 7 oz. (198.4 g) bottles, NDC 44523-617-07 To report a serious adverse event or obtain product information, call [phone]. Manufactured for: BIOCOMP PHARMA, INC. San Antonio, TX 78230 1355 827650 R0218

Լիազորման կարգավիճակը:

unapproved drug other

Ապրանքի հատկությունները

UREA- UREA CREAM
BIOCOMP 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 40% CREAM
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram contains 400 mg of urea in a vehicle consisting of:
carbomer, cetyl alcohol,
dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum,
propylene glycol, purified
water, sodium hydroxide and xanthan gum.
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 of the skin.
PHARMACOKINETICS:The mechanism of action of topically applied urea is
not yet known.
INDICATIONS:
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, as well
as damaged,
ingrown and devitalized nails.
CONTRAINDICATIONS:
This product is contraindicated in persons with known or suspected
hypersensitivity to
any of the ingredients of the product.
WARNING:
KEEP OUT OF REACH OF CHILDREN.
PRECAUTIONS:
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
GENERAL:This product 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.
INFORMATION FOR PATIENTS:Patients should discontinue the use of this
product if the
condition becomes worse or if a rash develops in the area being
treated or elsewhere.
Avoid contact