Description
Urea 41% Cream used to soften and moisturize dry, rough, and hyperkeratotic skin.
Urea 41 Cream
FDA Label NDC 85477-306
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Urea 41 (NDC 85477-306). 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 description, indications and usage, warnings, dosage and administration, how supplied, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications And Usage
Urea 41% Cream is indicated 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.
It is also indicated for the treatment of hyperkeratotic conditions such as:
dry, rough skin
dermatitis
psoriasis
xerosis
ichthyosis
eczema
keratosis pilaris
keratosis palmaris
keratoderma
corns and calluses
damaged, ingrown, or devitalized nails
Warnings
For external use only.
Avoid contact with eyes, lips, or mucous membranes.
Discontinue use and consult a physician if redness, irritation, or sensitivity occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage And Administration
Apply Urea 41% Cream to affected area(s) twice daily or as directed by a physician.
Rub into the skin until completely absorbed.
For nail conditions, apply to diseased or damaged nails twice daily or as directed by a physician.
How Supplied
Urea 41% Cream is supplied as:
8 oz (227 g) container
NDC: 85477-306-27
Dispensed by prescription.
Principal Display Panel
Urea Cream 41%
For dry, rough, cracked, and callused skin.
For external use only. Not for ophthalmic use.
8 oz (227 g)
Distributed by:
Oncora Pharma
Dallas, TX 75161
Pdp (Urea 41 1)
* Please review the disclaimer below.
