UREA- urea cream 
Stratus Pharamceuticals, 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 20% CREAM

Drug Facts

Active Ingredient

Urea 20%

Purpose

Keratolytic

Inactive Ingredients

Carbomer, Fragrance, Isopropyl Myristate, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearic Acid, Trolamine and Xanthan Gum.

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin. Do not use if known hypersensitivity to any of the listed ingredients.

Precautions

Stop use and ask a doctor if redness or irritation develops. Keep this and all other medications out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Pregnancy

If pregnant or breast feeding, ask a health professional before use.

Directions

Apply to the affected areas twice a day or as directed by a physician. Rub into the skin until completely absorbed.

Store at controlled room temperature 15° - 30°C (59° - 86°F). Protect from Freezing. SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION. See Crimp and end of carton for Lot Number and Expiration Date.

UC20(3)-200907

PRINCIPAL DISPLAY PANEL - 85 g Label

NDC 58980-610-30
Net WT. 3 oz. (85g)

UREA 20% CREAM
STRATUS

PHARMACEUTICALS INC

Softens and Moisturizes Severe Dry Skin

Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

Principal Display Panel - 85 g Label
UREA 
urea cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-610
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea 17 g  in 85 g
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58980-610-30 1 in 1 BOX
1 85 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved other 10/31/2008
Labeler - Stratus Pharamceuticals, Inc (789001641)
Establishment
Name Address ID/FEI Business Operations
Sonar Products, Inc 104283945 MANUFACTURE

Revised: 10/2009
Document Id: 450898ac-ec56-4cc7-a18f-f65b12e5aa65
Set id: 13835d67-4c10-4f32-9c6f-69d41ae9569c
Version: 1
Effective Time: 20091030
 
Stratus Pharamceuticals, Inc