WARNINGS AND PRECAUTIONS
For external use only. Keep away from eyes. If irritation develops, the use of Dermazene Cream should be discontinued and appropriate therapy instituted. Staining of the skin and fabrics may occur. If extensive areas are treated or if the occlusive 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 the corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tightfitting 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. Keep out of reach of children.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of hydrocortisone or Iodoquinol.
In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been conducted with iodoquinol.
Pregnancy Category C
Animal reproductive studies have not been conducted with Dermazene Cream. It is not known whether Dermazene Cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Dermazene Cream should be given to a pregnant woman only if clearly needed.
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 Dermazene Cream is administered to a nursing woman.
Safety and effectiveness in children under the age of 12 have not been established.