Urea gently dissolves the intercellular matrix, which results in loosening of the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas.
Indications and uses:
Known hypersensitivity to any of the listed ingredients.
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.
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea 42% Cloths are administered to a nursing woman.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
Dosage and administration:
Gently apply Urea 42% Cloths to affected skin twice per day, or as directed by a physician.
Urea 42% Cloths, NDC 68032-222-75, are supplied in a carton containing 30 foil pouches, each with a single-use medicated cloth ( 12 mL each).
Store at controlled room temperature 15 - 30 C (59 - 86 F). Protect from freezing.
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 08/08 222-11
Ingredients and appearance - Product information
Urea cloth- Urea
|Product Type||HUMAN PRESCRIPTION DRUG LABEL||Item Code (Source)||NDC: 68032-222|
|Route of Administration||Topical|
|Urea ( UNII: 8W8T17847W)( Urea - UNII: 8W8T17847W )||420 mgin 1 mL|
|Water||( UNII: 059QF0KO0R)|
|Glycerin||( UNII: PDC6A3C0OX)|
|Medium-chain triglycerides||( UNII: C9H2L21V7U)|
|Propylene glycol||( UNII: 6DC9Q167V3)|
|Xanthan gum||( UNII: TTV12P4NEE)|
|Edetate disodium||( UNII: 7FLD91C86K)|
|Pyrithione zinc||( UNII: R953O2RHZ5)|
|Alpha-tocopherol acetate||( UNII: 9E8X80D2L0)|
|Lactic acid||( UNII: 33X04XA5AT)|
|Citric acid monohydrate||( UNII: 2968PHW8QP)|
|Sodium citrate||( UNII: 1Q73Q2JULR)|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
|unapproved drug other||USA|