Otc - Active Ingredient
Active Ingredient: UREA 40%
Urea 40 Cream
FDA Label NDC 87021-603
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Krewe Pharma, Llc for the product Urea 40 (NDC 87021-603). 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: 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
KEEP OUT OF REACH OF CHILDREN. For External Use Only.
Otc - Do Not Use
Do not use: If allergic to any of the ingredients in the cream.
Otc - When Using
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
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
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
Storage: Store at 20°C (68°F - 77°F). Protect from freezing and excessive heat. Keep container tightly closed.
Otc - Questions
Questions? Call: 602-834-3759
Label:
Urea 40% Cream
* Please review the disclaimer below.
