Label: ALUVEA- urea cream
- NDC Code(s): 0259-1139-80
- Packager: Merz Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Updated April 13, 2011
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- SPL UNCLASSIFIED SECTION
(39% Urea Cream)
Aluvea™ (urea) cream, 39% is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin.
Each gram of Aluvea Cream contains 39% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax NF, glycerin 99.7% USP, isopropyl myristate, purified water, sorbitol 70% Solution USP, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate.Close
- 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.
- INDICATION AND USAGE
Urea 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.Close
Known hypersensitivity to any of the listed ingredientsClose
For external use only. Avoid contact with eyes, lips or mucous membranes.Close
Urea should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use.
It is not known whether Aluvea is excreted in human milk, therefore caution should be exercised when administering to a nursing mother.
- ADVERSE REACTIONS
Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication.Close
- DOSAGE AND ADMINISTRATIONS
Apply Aluvea to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.Close
- KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN
- HOW SUPPLIED
Aluvea is supplied in an 8oz. bottle.
- SPL UNCLASSIFIED SECTION
Merz Pharmaceuticals, LLC
Greensboro, NC 27410
- PRINCIPAL DISPLAY PANEL - 227g Carton
39% Urea Cream
FOR EXTERNAL USE ONLY
8 oz. (227g)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0259-1139 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea 39 g in 100 g Inactive Ingredients Ingredient Name Strength Dimethyl isosorbide (UNII: SA6A6V432S) Glycerin (UNII: PDC6A3C0OX) Isopropyl Myristate (UNII: 0RE8K4LNJS) Sorbitol (UNII: 506T60A25R) Tridecyl Stearate (UNII: A8OE252M6L) Neopentyl Glycol Dicaprate (UNII: 77T908SE82) Tridecyl Trimellitate (UNII: FY36J270ES) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0259-1139-80 1 in 1 CARTON 1 227 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/15/2011 Labeler - Merz Pharmaceuticals, LLC (126209282) Establishment Name Address ID/FEI Business Operations Crown Laboratories, Inc. 079035945 MANUFACTURE