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Urevia
urea 39 · Urevia is an over-the-counter drug containing urea 39, made by Blue Heron Pharmaceuticals, LLC.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
Usage: Intensely exfolitating and skin-softening cream with Urea 39%. Helps smooth and soften very, dry, rough, and thickened skin.
Drug facts
- Generic name
- urea 39
- Active ingredients
- Urea
- Dosage forms
- Cream
- Label holder
- Blue Heron Pharmaceuticals, LLC
- Label updated
- 06/04/2026
Active ingredients
Urevia 39% Cream Active Ingredient: UREA 39%
Purpose
Moisturizer
Uses
Usage: Intensely exfolitating and skin-softening cream with Urea 39%. 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.
Directions
Apply Urea 39% Cream to affected area(s) twice per day, or as directed by your physician. Rub in until completely absorbed.
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.
Do not use
If allergic to any of the ingredients in the cream.
When using this product
Directions: Apply Urea 39% Cream to affected area(s) twice per day, or as directed by your physician. Rub in until completely absorbed.
Stop use and ask a doctor
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.
Keep out of reach of children
For External Use Only.
Other information
Storage: Store at 20°C (68°F - 77°F). Protect from freezing and excessive heat. Keep container tightly closed.
Inactive ingredients
Water (Aqua), Glyceryl Stearate SE, Propylene Glycol, Mineral Oil (Paraffinum Liquidum), Stearyl Alcohol, Petrolatum, Cetyl Alcohol, Phenoxyethanol, Gluconolactone, Carbomer, Polyacrylamide, Xanthan Gum, Citric Acid, C13-14 Isoalkane, Ethylhexylglycerin, Aminomethyl Propanol, Sodium Phytate, Laureth-7, Sodium Citrate
Questions?
Call: 813-380-0271
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Cream | 390 mg/g | topical | 1 |
Manufacturers and labels
1 FDA label
- Blue Heron Pharmaceuticals, LLCShown hereLabel 06/04/2026 · NDC 85622-602Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrug10/06/2021ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X, Chelidonium Majus...Washington Homeopathic Products, Inc. · 4 products · Out-of-specification test results obtained for identification...
- Class IIDrug11/27/2019StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x...Washington Homeopathic Products, Inc. · CGMP Deviations: products were not manufactured under current good...
- Class IIDrug10/09/2019C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia...Colonia Care Pharmacy · Lack of Assurance of Sterility: product sterility cannot be...
- Class IIDrug03/22/2017UREA 40% Cream, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676Synergy Rx · Lack of Assurance of Sterility: There are also CGMP Deviations.
- Class IIIDrug08/31/2016Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only...Stratus Pharmaceuticals Inc · Crystallization; Complaints that cream appears to have crystallized
Urevia: common questions
- What is Urevia used for?
- Usage: Intensely exfolitating and skin-softening cream with Urea 39%. Helps smooth and soften very, dry, rough, and thickened skin.
- Is Urevia a prescription drug?
- No. Urevia is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Urevia?
- Yes. Other FDA-listed products with the same active ingredients include Avenaster Fungal Nail Care Duo Set (Day), Urea 20, Urea 39, Urea 40.
- Who makes Urevia?
- Blue Heron Pharmaceuticals, LLC lists Urevia with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 06/04/2026 · Label text is shown as published by the manufacturer. Not medical advice