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warnings and cautions
WARNINGS AND PRECAUTIONS For external use only. Keep away from eyes. If irritation develops, the use of QUINJA should be discontinued and appropriate therapy instituted. Some discoloration of the skin, hair and fabrics may occur, but can be removed with normal cleansing and laundry. Not intended for use on infants or under diapers or 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 over- growth of non-susceptible organisms requiring appropriate therapy. Keep out of reach of children. Carcinogenesis, Mutagenisis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of the effect on fertility of Iodoquinol. Mutagenicity studies have not been performed with Iodoquinol. Pregnancy Category C: Animal reproductive studies have not been conducted with QUINJA. It is not known whether QUINJA can cause fetal harm when administered to pregnant women or can affect reproductive capacity. QUINJA should be given to pregnant women only if clearly needed. 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 QUINJA is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.
ADVERSE REACTIONS Adverse reactions from topical use of QUINJA is expected to be low when used as directed, due to low concentration of Iodoquinol present in this topical gel. To achieve the equivalent of a common daily oral dose of nearly 2,000 mg Iodoquinol, one will need to use more than 2 full tubes of 60 g QUINJA in a single application. Adverse reactions from oral form of Iodoquinol (nearly 2,000 mg daily) have been reported: various forms of skin eruptions, hives, itching, nausea, vomiting, abdominal cramps, diarrhea, anusitis, fever, chills, headache, vertigo and enlargement of thyroid.