Urea 20 by Oncor Pharmaceuticals Urea 20% Cream

Urea 20 by

Drug Labeling and Warnings

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

Drug Details [pdf]

UREA 20- urea cream 
Oncor Pharmaceuticals

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%

Intensive Hydrating Cream:

• Moisturizes to help relieve rough, cracked skin caused by dryness.
• Helps to restore skin's natural moisture barrier.

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

Usage: Deeply Moisturizes Skin.

WARNINGS SECTION

Caution:Do not use on tender skin areas such as the face, neck, or scalp. Do not apply to broken skin, If redness occurs, discontinue use. Avoid contact with eyes.

Do not use if safety seal on the tube is broken or missing.

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.

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.

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST),
at 1-443-876-7900 or FDA at 1-800-FDA-1088.

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

Manufactured In USA For:

ONCOR PHARMACEUTICALS
8815 Center Park Dr Suite 430
Columbia
Maryland 21045

Rev. 05/24

ONCOR PHARMACEUTICALS

NDC: 83720-561-03

UREA 20%

Intensive Hydrating Cream

Deeply Moisturizes Skin

For external use only

NET WT. 3 OZ. (85 g)

ONCOR PHARMACEUTICALS

NDC: 83720-561-03

UREA 20% Cream

Intensive Hydrating Cream

Deeply Moisturizes Skin

For external use only

NET WT. 3 OZ. (85 g)

UREA 20 
urea cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83720-561
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: 83720-561-03	1 in 1 CARTON	09/17/2024	09/17/2024
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 83720-561-01	1 in 1 CARTON	09/17/2024	09/17/2024
2		28.3 g in 1 CARTON; Type 0: Not a Combination Product
3	NDC: 83720-561-07	1 in 1 CARTON	09/17/2024	09/17/2024
3		198.4 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/17/2024	09/17/2024

Labeler - Oncor Pharmaceuticals (119032580)

Registrant - Oncor Pharmaceuticals (119032580)

Revised: 9/2024

Document Id: 22555bf2-2e39-de0b-e063-6394a90ab03a

34390-5

Set id: 2505714f-4d96-4456-a831-7cf304b15682

Version: 3

Effective Time: 20240917