UREDEX 200 mg/g
UREA · CREAM · Blue Heron Pharmaceuticals, LLC
UREDEX is a cream containing urea at 200 mg/g, taken topical. Manufactured by Blue Heron Pharmaceuticals, LLC.
Key Facts
- Brand Name
- UREDEX
- Generic Name
- UREA
- NDC Code (Product)
85622-601- Manufacturer
- Blue Heron Pharmaceuticals, LLC
- Strength
- 200 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Marketing Start
- 01/07/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
Warnings
WARNING: KEEP OUT OF REACH OF CHILDREN.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Adverse Reactions
ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
Frequently Asked Questions
What is UREDEX used for?
UREDEX contains UREA. It is a cream taken topical. Consult your doctor for specific uses.
Is UREDEX a controlled substance?
UREDEX is not classified as a controlled substance by the DEA.
What is the generic name for UREDEX?
The generic name for UREDEX is UREA. There are 12 other brand versions of UREA.
What is the NDC code for UREDEX 200 mg/g?
The NDC (National Drug Code) for UREDEX 200 mg/g is 85622-601, listed by Blue Heron Pharmaceuticals, LLC.
Other Urea Brands
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- Miracle FootCream Lemon.5 g/100g82145-0006
- DERMACURE410 mg/g85477-909
- UREVEX200 mg/g85622-605
- Urea 40%400 mg/g39328-019
- Urea Cream 40 Percent400 mg/g58657-489
- UREA400 mg/g81542-201
- Miracle FootCream Lavender.5 g/100g82145-0005
- Urea 40 Percent400 mg/g71335-2890
- Urea Cream 40%400 mg/g71399-8456
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)