PRECAUTIONS
General
Should not be used when acute inflammation or exudation is present as increased absorption may occur.
Information for Patients
Application to skin or scalp may produce skin irritation or sensitization. If sensitivity reactions occur, use should be discontinued.
May be irritating to mucous membranes of the eyes and contact with this area should be avoided.
When applied to the body for treatment of tinea versicolor, Selenium Sulfide Lotion, USP 2.5% may produce skin irritation especially in the genital area and where skin folds occur. These areas should be thoroughly rinsed after application.
Carcinogenesis
Studies in mice using dermal application of 25% and 50% solutions of 2.5% Selenium Sulfide Lotion, over an 88 week period, indicated no carcinogenic effects.
Pregnancy
WHEN USED ON BODY SURFACES FOR THE TREATMENT OF TINEA VERSICOLOR, SELENIUM SULFIDE IS CLASSIFIED AS PREGNANCY CATEGORY "C".
Animal reproduction studies have not been conducted with Selenium Sulfide Lotion. It is also not known whether Selenium Sulfide Lotion can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances Selenium Sulfide Lotion should not be used for the treatment of tinea versicolor in pregnant women.
Pediatric Use
Safety and effectiveness in infants have not been established.
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