Document
DailyMed Label: Urea 39% Cream
Title
DailyMed Label: UREA
Date
2024
Document type
DailyMed Prescription
Name
UREA
Generic name
UREA
Manufacturer
AvKARE
Product information
NDC: 42291-849
Product information
NDC: 42291-849
Description
Rx Only
For external use only. Not for ophthalmic use.
Description
Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40%contains 40% urea as an active ingredient, and the following inactive ingredients:
Carbomer, Cetearyl Alcohol, Glycerin,
Glyceryl Stearate SE, Mineral Oil, Purified Water,
White Petrolatum
Urea is a diamide of carbonic acid with the following chemical structure:
structure
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
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.
Contraindications
Known hypersensitivity to any of the listed ingredients.
Precautions
This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which
it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.
Adverse reactions
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.
How supplied
Urea 40% Cream
1 oz. (28.35 g):
Bottle NDC 42291-849-28
Tube NDC 42291-849-29
Urea 40% Cream
3 oz. (85 g): NDC 42291-849-85
Urea 40% Cream
7 oz. (198.4 g): NDC 42291-849-19
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.
Manufactured for:
AvKARE
Pulaski, TN 38478
AV 06/22
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.
Package label
28.35
29
85
198.4
10 organizations
2 products
Product
CEM-UreaOrganization
bryant ranch prepackProduct
Urea 39% CreamOrganization
BioComp Pharma, Inc.Organization
AvKAREOrganization
Bantry Pharma, LLCOrganization
AUSTIN PHARMACEUTICALS, LLCOrganization
AvPAKOrganization
Palmetto Pharmaceuticals Inc.Organization
KMM Pharmaceuticals, LLCOrganization
Exact-Rx, Inc.Organization
Cintex Services, LLC