warnings and cautions
WARNINGS: KEEP OUT OF REACH OF CHILDREN. PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous membranes. Information for Patients: If irritation develops, the use of this product should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. Not intended for use on infants or under diapers or occlusive dressings. If extensive areas are treated or if the occlusive dressing technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if iodoquinol is present in the diaper or urine. Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been performed with iodoquinol. Pregnancy: 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 a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.