Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

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, keratoderma, corns and calluses, as well as damaged, devitalized and ingrown nails.

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Advisory information

contraindications
Known hypersensitivity to any of the listed ingredients.
Adverse reactions
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

Usage information

Dosing and administration
DIRECTIONS FOR NAILS: Apply CEM-UreaTM (45% Urea) to diseased or damaged nail tissue twice per day, or as directed by a physician. DIRECTIONS FOR SKIN: Apply CEM-UreaTM (45% Urea) to affected area(s) twice per day, or as directed by a physician.
Pregnancy and lactation
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when CEM-UreaTM (45% Urea) is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

More information

Category Value
Agency product number 8W8T17847W
Orphan designation No
Product NDC 42546-100
Date Last Revised 16-08-2011
Type HUMAN PRESCRIPTION DRUG
RXCUI 1242631
Storage and handling Store at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing.
Marketing authorisation holder PruGen, Inc.