Keratol 45 Cream

Generic name:urea
Dosage form: cream
Drug class:Topical emollients

Medically reviewed by Drugs.com. Last updated on Jan 24, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION:KeratolTM 45 Cream is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of KeratolTM 45 Cream contains 45% Urea, camphor, edetate disodium, eucalyptus oil, ethyl alcohol, hydroxyethyl cellulose, menthol, purified water and titanium dioxide.

Urea is a diamide of carbonic acid with following chemical structure:

CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMOCOKINETICS: The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USES: 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.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes,

PRECAUTIONS: This medication is to be u..