NURSING MOTHERS SECTION.

NURSING MOTHERSIt is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea 40% is administered to nursing woman.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

All prescription substitutions and or recommendations using this product shall be made subject to state and federal statutes as applicable. Pleaes note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Please see package insert for more details.. oz label. oz label.

PHARMACOKINETICS SECTION.

PharmacokineticsThe mechanism of action of topically applied urea is not yet known.

PRECAUTIONS SECTION.

PrecautionsThis medication is to be used as directed by 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 physician.

PREGNANCY SECTION.

PREGNANACYPregnancy 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, Urea 40% should be given to pregnant woman only if clearly needed.

WARNINGS SECTION.

WarningsFor topical use only. Avoid contact with eyes, lips or mucous membranes.

HOW SUPPLIED SECTION.

How SuppliedUrea 40% Cream oz.(28.35 g): NDC 0904-7167-23; Urea 40% Cream oz.(85 g): NDC 0904-7167-83 Store at room temperature 15C 30C (59F 86F). Protect from freezing. Keep bottle tightly closed.

INACTIVE INGREDIENT SECTION.

Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Xanthan Gum.

INDICATIONS & USAGE SECTION.

Indications and UsageFor 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 eshar. 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.

ADVERSE REACTIONS SECTION.

Adverse ReactionsTransient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.

CLINICAL PHARMACOLOGY SECTION.

Clinical PharmacologyUrea 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.

CONTRAINDICATIONS SECTION.

ContraindicationsKnown hypersensitivity to any of the listed ingredients.

DESCRIPTION SECTION.

DescriptionUrea 40% is keratolytic emollient which is 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: Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Xanthan Gum.Urea is diamide of carbonic acid with the following chemical structure:. image description.

DOSAGE & ADMINISTRATION SECTION.

Dosage and AdministrationApply 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 physician.All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending prescription substitution using this product shall make such recommendations based on each persons professional opinion and knowledge, upon evaluation of the active ingredients, excipients, inactive ingredients and chemical information provided herein.