Storage and handling
Storage: Store at 20°C (68°F - 77°F). Protect from freezing and excessive heat. Keep container tightly closed.
Urea 40% Cream
- Manufacturer
- Krewe Pharma, LLC | Pure Source, Inc.
- Effective date
- 2026-06-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-06-11 05:10:30
Label at a glance#
ProductUrea 40
Active ingredientUREA
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient: UREA 40%
OTC - PURPOSE SECTION
Purpose: Moisturizer
INDICATIONS & USAGE SECTION
Usage: Intensely exfolitating and skin-softening cream with Urea 40%. Helps smooth and soften very, dry, rough, and thickened skin. Suitable for targeted application on areas with very dry, hardened or thick skin, rough patches and calluses, uneven, scaly, or flaky skin texture and thickened nail surface appearance. Helps soften and improve the cosmetic appearance of thickened or irregular nails.
WARNINGS SECTION
Caution: Discontinue use and consult a physician if redness or Irritation occurs.
When using this product avoid contact with eyes, lips or mucous membranes.
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: If allergic to any of the ingredients in the cream.
OTC - WHEN USING SECTION
Directions: Apply Urea 40% Cream to affected area(s) twice per day, or as directed by your physician. Rub in until completely absorbed.
OTC - STOP USE SECTION
Stop Use: Discontinue use and consult a physician if redness or Irritation occurs.
When using this product avoid contact with eyes, lips or mucous membranes.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Water (Aqua), Urea*, Glyceryl Stearate SE, Propylene Glycol, Steraryl Alcohol, Cetyl Alcohol, Mineral Oil (Paraffinum Liquidum), Butyrospermum Parkii (Shea) Butter, Petrolatum, C12-15 Alkyl Benzoate, Phenoxyethanol, Gluconolactone, Polyacrylamide, C13-14 Isoalkane, Xanthan Gum, Ethylhexylglycerin, Citric Acid, Sodium Phytate, Laureth-7, Sodium Citrate
STORAGE AND HANDLING SECTION
Storage: Store at 20°C (68°F - 77°F). Protect from freezing and excessive heat. Keep container tightly closed.
OTC - QUESTIONS SECTION
Questions? Call: 602-834-3759
Label:
Urea 40% Cream
Products#
Every source-derived product name is available through these pages.
- Urea 40
- Urea
- WATER
- GLYCERYL STEARATE
- PROPYLENE GLYCOL
- MINERAL OIL
- STEARYL ALCOHOL
- PETROLATUM
- CETYL ALCOHOL
- PHENOXYETHANOL
- GLUCONOLACTONE
- POLYACRYLAMIDE (10000 MW)
- XANTHAN GUM
- CITRIC ACID
- ETHYLHEXYLGLYCERIN
- SODIUM PHYTATE
- LAURETH-7
- SODIUM CITRATE
- BUTYROSPERMUM PARKII (SHEA) BUTTER
- C12-15 ALKYL BENZOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87021-603 | 87021-603-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 40 | UREA | Krewe Pharma, LLC | 415c4efd-95bd-4276-900c-e9da70266cd4 | 2026-06-02 | Warnings | 87021-603-04 87021-603 87021060304 74f07bb6-27de-49ad-bfc6-5ea8074e57af 415c4efd-95bd-4276-900c-e9da70266cd4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.