Urea 20% Cream

Urea 20% Cream
SPL v4
SPL
SPL Set ID e994fa05-a457-2555-e053-2a95a90ae83b
Route
TOPICAL
Published
Effective Date 2022-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Urea (200 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Cetyl Alcohol Glycerin Glyceryl Stearate Se Mineral Oil Water Stearyl Alcohol Triacetin White Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-09-19

Description

Active Ingredient: UREA 20%


Medication Information

Indications and Usage

Usage: Soothes, Softens and Moisturizes Dry Rough Skin.

Description

Active Ingredient: UREA 20%

Section 44425-7

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]

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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.

Section 50570-1

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.

Section 51727-6

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

Section 53413-1

Questions or comments? 1-855-361-3993

Section 55105-1

Purpose: Moisturizer

Section 55106-9

Active Ingredient: UREA 20%

Warnings Section

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

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)


Structured Label Content

Indications and Usage (34067-9)

Usage: Soothes, Softens and Moisturizes Dry Rough Skin.

Section 44425-7 (44425-7)

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]

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments? 1-855-361-3993

Section 55105-1 (55105-1)

Purpose: Moisturizer

Section 55106-9 (55106-9)

Active Ingredient: UREA 20%

Warnings Section (WARNINGS SECTION)

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

Package Label.principal Display Panel (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)