UREA 40 g/100g
UREA · LOTION · AKRON PHARMA INC
UREA is a lotion containing urea at 40 g/100g, taken topical. Manufactured by AKRON PHARMA INC.
Key Facts
- Brand Name
- UREA
- Generic Name
- UREA
- NDC Code (Product)
71399-8455- Manufacturer
- AKRON PHARMA INC
- Strength
- 40 g/100g
- Dosage Form
- LOTION
- Route
- TOPICAL
- Marketing Status
- Marketing Start
- 09/13/2024
Recall History
Exact-Rx Inc
Crystallization; complaints received by the manufacturer of crystals forming in product
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Colonia Care Pharmacy
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Geritrex Corp
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Stratus Pharmaceuticals Inc
Crystallization; Complaints that cream appears to have crystallized
Geritrex Corp
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Indications and Usage 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 Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
Warnings
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.
Contraindications
Contraindications Known hypersensitivity to any of the listed ingredients.
Adverse Reactions
Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at 1-877-250-3427; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Frequently Asked Questions
What is UREA used for?
UREA contains UREA. It is a lotion taken topical. Consult your doctor for specific uses.
Is UREA a controlled substance?
UREA is not classified as a controlled substance by the DEA.
What is the generic name for UREA?
The generic name for UREA is UREA. There are 11 other brand versions of UREA.
What is the NDC code for UREA 40 g/100g?
The NDC (National Drug Code) for UREA 40 g/100g is 71399-8455, listed by AKRON PHARMA INC.
Other UREA Dosages
Other Urea Brands
See all →- Urea Cream 40 Percent400 mg/g72162-2203
- 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
- Miracle FootCream Lavender.5 g/100g82145-0005
- Urea 40 Percent400 mg/g71335-2890
- Urea Cream 40%400 mg/g71399-8456
- Urea 40 Percent400 mg/g72162-1668
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)