UREA UREA BRYANT RANCH PREPACK FDA Approved Rx Only For external use only. Not for ophthalmic use. Description Urea Cream 39% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea Cream 39% contains 39% urea as an active ingredient, and the following inactive ingredients: Water, Propylene Glycol, Glyceryl Stearate, Mineral Oil, Cetyl Alcohol, Carbomer, Petrolatum, Xanthan Gum and Sodium Hydroxide. Urea is a diamide of carbonic acid with the following chemical structure:
Generic: UREA
Mfr: BRYANT RANCH PREPACK FDA Rx Only
FunFoxMeds bottle
Substance Urea
Route
TOPICAL
Package NDC

Drug Facts

Composition & Profile

Strengths
39 % 226.8 g
Treats Conditions
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
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
8W8T17847W
Packaging

How Supplied Urea 39% Cream 8 oz. (226.8g): NDC 63629-2036-1 Store at room temperature 15°C - 30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504; Urea 39% Cream, #8oz Label

Package Descriptions
  • How Supplied Urea 39% Cream 8 oz. (226.8g): NDC 63629-2036-1 Store at room temperature 15°C - 30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
  • Urea 39% Cream, #8oz Label

Overview

Rx Only For external use only. Not for ophthalmic use. Description Urea Cream 39% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea Cream 39% contains 39% urea as an active ingredient, and the following inactive ingredients: Water, Propylene Glycol, Glyceryl Stearate, Mineral Oil, Cetyl Alcohol, Carbomer, Petrolatum, Xanthan Gum and Sodium Hydroxide. Urea is a diamide of carbonic acid with the following chemical structure:

Indications & 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

Apply Urea Cream 39% 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 & Precautions
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.
Contraindications

Known hypersensitivity to any of the listed ingredients.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.


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