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

INDICATIONS AND USAGE

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-610
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea17 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-610-301 in 1 BOX10/31/200807/31/2017
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/31/200807/31/2017
Labeler - Stratus Pharamceuticals, Inc (789001641)

Revised: 10/2017
Document Id: b9570d94-302f-4ce1-9cef-7653ae97da35
Set id: 13835d67-4c10-4f32-9c6f-69d41ae9569c
Version: 2
Effective Time: 20171026
 
Stratus Pharamceuticals, Inc