Urea (25%)

Indications

Adults & children over 12 years: It is intended to be used for the symptomatic treatment of heels & feet anhydrosis including in consumers and diabetics.

Pharmacology

Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose-dependent. Most of its therapeutic application depends on its hygroscopic properties. The hygroscopic property is due to its ability to cause a configurational change in proteins in the stratum corneum. Urea gently dissolves the intracellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.

Dosage And Administration

Apply enough Urea 25% Cream to cover affected area, once or twice daily or as directed by the physician. For external use only.

Interaction

No hazardous drug interaction has been reported.

Contraindications

Allergy to any of the ingredients of this product.

Side Effects

No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.

Pregnancy And Lactation

There are no adequate & well-controlled studies in pregnant women. Urea should only be used if the anticipated benefits outweigh the risks.

Precautions And Warnings

Avoid contact with eyes. Do not use, if sensitive to any of the ingredients, on genitals or other areas of sensitive skin, on skin that is badly cracked, infected or bleeding and at the same time as other skin care products. Stop use if skin irritation or rash occurs during use.

Therapeutic Class

Topical urea preparations.

Storage Conditions

Store in a cool & dry place, protect from light. Do not freeze.