UREA 20- urea gel 
AvPAK

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

Active Ingredient: UREA 20%

Purpose: Moisturizer

Usage: Soothes, Softens and Moisturizes Dry Rough Skin.

WARNINGS SECTION

Caution: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN. For External Use Only.

Do not use: Do not use if safety seal on the tube is broken or missing. For lot number and exp. date, see crimp of tube or carton.

Directions: Apply to desired areas of the hands, feet, knees, or elbows twice daily, or as directed by a physician. Rub into the skin until fully absorbed. Do not use on tender skin areas such as the face, neck, or scalp.

Stop use: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.

Inactive Ingredients: Cetyl Alcohol, Carbomer, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, Stearyl Alcohol, Triacetin, White Petrolatum.

Storage: Store at 20°C (68°F - 77°F), excursions permitted between 15°C and 30°C (59°F - 86°F). Protect from Freezing. Store in a cool dry place. [See USP Controlled Room Temperature]

Questions or comments? 1-855-361-3993

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UREA 20% Cream

FOR EXTERNAL USE ONLY.

Soothes, Softens and Moisturizes Dry Rough Skin

AvKARE


NET WT. 3 OZ. (85 g)


Manufactured for: AvKARE,
Pulaski, TN 38478
www.avkare.com
Questions or comments? 1-855-361-3993 AV 04/22

Carton

UREA 20% Cream

Product No. 50268-820-85

FOR EXTERNAL USE ONLY.

Soothes, Softens and Moisturizes Dry Rough Skin

AvKARE


NET WT. 3 OZ. (85 g)

tube
UREA 20 
urea gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-820
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
MINERAL OIL (UNII: T5L8T28FGP)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TRIACETIN (UNII: XHX3C3X673)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
Product Characteristics
Colorwhite (Opaque White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50268-820-851 in 1 CARTON09/19/2022
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 other09/19/2022
Labeler - AvPAK (832926666)

Revised: 3/2024
Document Id: 13039452-bcbc-8b55-e063-6394a90a558c
Set id: e994fa05-a457-2555-e053-2a95a90ae83b
Version: 3
Effective Time: 20240306
 
AvPAK