Urea 20 by AvPAK UREA 20- urea gel

Urea 20 by

Drug Labeling and Warnings

Urea 20 by is a Otc medication manufactured, distributed, or labeled by AvPAK. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: UREA 20%

PURPOSE

Purpose: Moisturizer

INDICATIONS & USAGE

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

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

DO NOT USE

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.

WHEN USING

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

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

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

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

STORAGE AND HANDLING

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

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

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)

INGREDIENTS AND APPEARANCE

UREA 20 
urea gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50268-820
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
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
Color	white (Opaque White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50268-820-85	1 in 1 CARTON	09/19/2022
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/19/2022

Labeler - AvPAK (832926666)