Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameUREA
Labeler / manufacturerAkron Pharma Inc.
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC71399-8456
Label effective date2024-09-25
Official product label reference
Urea Cream 40% — Akron Pharma Inc.
This page contains 12 source sections for UREA, topical route. Label set 0ce643e9-cf13-4b51-8ffd-8d5636d73e51, version 3.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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 eshar. 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 and administration — label text
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. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluation of the active ingredients, excipients, inactive ingredients and chemical information provided herein.
Contraindications
Contraindications Known hypersensitivity to any of the listed ingredients.
Warnings
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes. KEEP OUT OF REACH OF CHILDREN.
Adverse reactions
Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication. To report a serious adverse event or obtain product information, call 1-877-255-6999.
Unclassified section
Urea 40% Rx Only For topical use only. Not for ophthalmic use.
Description Each gram contains 400 mg of urea in a vehicle consisting of: cetyl alcohol, glycerin monostearate, phosphomer X-polymer, mineral oil, propylene glycol, purified water, trolamine 99%, white petrolatum, xanthan gum. str
Clinical pharmacology
Clinical Pharmacology Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.
Pharmacokinetics
Pharmacokinetics The mechanism of action of topically applied urea is not yet known.
Precautions
Precautions FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous membranes.
Pregnancy
PREGNANACY Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea 40% should be given to a pregnant woman only if clearly needed.
Breastfeeding
NURSING MOTHERS It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea 40% is administered to a nursing woman.
Supply and packaging
How Supplied Urea 40% Cream 1 oz.(28.35 g): NDC 71399-8456-1; Urea 40% Cream 3 oz.(85 g): NDC NDC 71399-8456-3; Urea 40% Cream 7 oz.(198.45 g): NDC NDC 71399-8456-7 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing and excessive heat. Keep bottle tightly closed. Manufactured for: Akron Pharma Inc., Fairfield, NJ-07004 www.akronpharma.com Manufactured In USA
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.