KERALAC- urea cream

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Brava Pharmaceuticals, LLC

INN (Alþjóðlegt nafn):

UREA

Samsetning:

UREA 470 mg in 1 g

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

This product is a keratolytic emollient useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

Vörulýsing:

5 oz. (142 g) bottles, NDC 57883-401-05 To report a serious adverse event or obtain product information, call [phone]. Manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 827734

Leyfisstaða:

unapproved drug other

Vara einkenni

KERALAC- UREA CREAM
BRAVA PHARMACEUTICALS, LLC
_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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KERALAC (UREA 47%) CREAM
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram contains 470 mg of urea in a vehicle consisting of: purified
water, SD alcohol 40B 200
proof, hydroxyethyl cellulose, titanium dioxide, disodium EDTA,
eucalyptus oil, menthol and camphor.
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 AND USAGE:
This product is a keratolytic emollient useful for the treatment of
hyperkeratotic conditions such as dry,
rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis,
eczema, psoriasis, keratoses and
calluses.
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 with eyes, lips and
mucous membranes.
CARCINOGENESIS, MUTAGENESIS AND IMPAIRMENT OF FERTILITY: Long-term
animal studies for
carcinogenic potential have not been performed on this product to
date. Studies on reproduction and
fertilit