MEDPURA Urea 20Intensive Hydrating Cream 

Urea 20 by

Drug Labeling and Warnings

Urea 20 by is a Other medication manufactured, distributed, or labeled by Akron Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UREA 20- urea cream 
Akron Pharma Inc.

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MEDPURA Urea 20
Intensive Hydrating Cream 

MEDPURA Urea20

Deeply Moisturizes Skin

For External use only

INTENSIVE HYDRATING CREAM

• Moisturizes to help relieve rough, cracked skin caused by dryness
• Works to slough away dry, damaged skin  
• Helps to restore skin’s natural moisture barrier

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.

INGREDIENTS: purified water, urea, mineral oil, white petrolatum, glyceryl monostearate, propylene glycol, cetyl alcohol, purified water, xanthan gum, trolamine 99%, phosphomer x polymer.

CAUTION: USE ONLY AS DIRECTED. FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN

STORAGE

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing and avoid
excessive heat.

Questions or comments?
Call 1-877-255-6999.

Manufactured for:

Akron Pharma, Inc.,

Fairfield, NJ-07004

www.akronpharma.com

UREA 20 
urea cream

Product Information
Product Type	COSMETIC	Item Code (Source)	71399-8434
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
TROLAMINE (UNII: 9O3K93S3TK)
2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE (UNII: 59RU860S8D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	71399-8434-3	1 in 1 CARTON
1		85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/29/2023

Labeler - Akron Pharma Inc. (067878881)

Revised: 12/2023

Document Id: 2a554e89-1a77-439c-8caa-cf038a90ec81

58474-8

Set id: 982e54c8-7c17-44fe-b05b-d3df03c45493

Version: 1

Effective Time: 20231208