ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS:.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY:.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:.

DESCRIPTION SECTION.

DESCRIPTION:. This product is keratolytic, emollient which is gentle, yet potent, tissue softener for skin.Each gram contains 390 mg of urea in vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, sodium hydroxide, water, and xanthan gum.Urea is diamide of carbonic acid with the following chemical structure:. structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:.

HOW SUPPLIED SECTION.

HOW SUPPLIED:.

INDICATIONS & USAGE SECTION.

INDICATIONS:.

PRECAUTIONS SECTION.

PRECAUTIONS:.

WARNINGS SECTION.

WARNING:. KEEP OUT OF REACH OF CHILDREN.

PREGNANCY SECTION.

Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to pregnant woman. This product should be used by pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

SPL UNCLASSIFIED SECTION.

GENERAL:. This product 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.

STORAGE AND HANDLING SECTION.

STORAGE:. Store at 20C to 25C (68F to 77F), excursions permitted between 15C to 30C (between 59F to 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); however, such exposure should be minimized.