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]
Urea 20% Cream
- Manufacturer
- AvPAK
- Effective date
- 2026-01-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:32:48
Label at a glance#
ProductUrea 20
Active ingredientUREA
Label structure12 sections
Contacts and useful links#
Websitewww.avkare.com
www.avkare.com
www.avkare.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient: UREA 20%
OTC - PURPOSE SECTION
Purpose: Moisturizer
INDICATIONS & USAGE SECTION
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 SECTION
KEEP OUT OF REACH OF CHILDREN. For External Use Only.
OTC - DO NOT USE SECTION
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 SECTION
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 SECTION
Stop use: Do not apply to broken skin. If redness occurs, discontinue use. Avoid contact with eyes.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Cetyl Alcohol, Carbomer, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, Stearyl Alcohol, Triacetin, White Petrolatum.
STORAGE AND HANDLING SECTION
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 SECTION
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)
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50268-820-85 | Urea 20 | 1 in 1 CARTON | GEL | 1 | 4 | |
| 50268-820-85 | Urea 20 | 85 g in 1 TUBE | GEL | 85 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50268-820-85 | GM - Gram | 50268-820 | f43ce712-7d5f-42c8-82fc-a34279c41305 | 1 | 2022-10-06 |
Products#
Every source-derived product name is available through these pages.
- Urea 20
- Urea
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- CETYL ALCOHOL
- GLYCERIN
- GLYCERYL STEARATE SE
- MINERAL OIL
- WATER
- STEARYL ALCOHOL
- TRIACETIN
- WHITE PETROLATUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50268-820 | 50268-820-85 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL STEARATE SE | FCZ5MH785I | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| WHITE PETROLATUM | B6E5W8RQJ4 | IACT |
| UREA | 8W8T17847W | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Urea 20 | UREA | AvPAK | e994fa05-a457-2555-e053-2a95a90ae83b | 2026-01-12 | Warnings | 50268-820-85 50268-820 50268082085 48379414-bcb9-1797-e063-6394a90aa8fd e994fa05-a457-2555-e053-2a95a90ae83b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.