METOPIC- urea cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Method Pharmaceuticals, LLC

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

This product is 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.

Produkt oppsummering:

This product is supplied in the following size(s): 8 oz. (227 g) bottles, NDC # 58657-485-08 To report a serious adverse event or obtain product information, call 877-250-3427 To report  a serious adverse event, please contact Method Pharmaceuticals at [phone]; email at [e-mail]; or call FDA at (800) FDA-1088. Manufactured for: Method Pharmaceuticals, LLC Fort Worth, Texas 76118 Rev. 03/18

Autorisasjon status:

unapproved drug other

Preparatomtale

METOPIC- UREA CREAM
METHOD 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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METOPIC CREAM
NDC 58657-485-08
METOPIC CREAM
(UREA 41%)
FOR EXTERNAL USE ONLY RX ONLY
NET WT. 8 OZ. (227 G
METOPIC
METHOD 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._
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METOPIC CREAM DESCRIPTION:
Each gram contains 410 mg of urea in a vehicle consisting of:
ceteareth-25, ceteareth-
6, cetyl alcohol, methylparaben, paraffin, propylene glycol,
propylparaben, purified water, stearyl
alcohol, 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:
This product is 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.
WARNINGS:
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF
CHILDREN.
Avoid contact with eyes, lips and mucous membranes.
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