The following Structured Product Label (SPL) was submitted to the FDA by Prugen, Inc. for the product Cem-urea (NDC 42546-100). 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, clinical pharmacology, pharmacokinetics, indications & usage, contraindications, warnings and precautions, pregnancy, nursing mothers, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
For external use only. Avoid contact with eyes, lips or mucous membranes.
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.
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, CEM-UreaTM (45% Urea) should be given to a pregnant woman only if clearly needed.
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.
Transient stinging, burning, itching or irritation may occur and normally disappear
on discontinuing the medication.
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.
CEM-UreaTM (45% Urea) 20 mL tube, NDC 42546-100-20
Store at controlled room temperature 15°-30° C (59°-86° F).
Protect from freezing.
NDC 42546-100-20
CEM-Urea Pre-Filled Applicator 45% urea
In a vehicle containing Menthol, Camphor, and Eucalyptus Oil
Rx only
0.68 FL OZ (20 mL)
PruGen, Inc. Pharmaceuticals
Image Of Tube Label (Tube)
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