Otc - Active Ingredient
Active Ingredient: UREA 20%
Urea 20 Gel
FDA Label NDC 50268-820
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avpak for the product Urea 20 (NDC 50268-820). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings section, otc - keep out of reach of children, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. For External Use Only.
Otc - 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.
Otc - 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.
Otc - Stop Use
Stop use: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.
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]
Otc - 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
Carton (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 (Tube)
* Please review the disclaimer below.
