Selenium Sulfide Drug Information

For the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff.

See application instructions on rear panel of this bottle. For treatment of dandruff and seborrheic dermatitis: For the usual case, two applications each week for two weeks will afford control. After this, the suspension may be used at less frequent intervals - weekly, every two weeks, or even every 3 or 4 weeks in some cases.

The preparation should not be applied more frequently than required to maintain control. For treatment of tinea versicolor: Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse the body thoroughly.

Repeat this procedure once a day for seven days.

In decreasing order of severity: skin irritation, occasional reports of increase in amount of normal hair loss, discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.

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 Topical Suspension USP, 2.5% (Lotion). It is also not known whether Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances Selenium Sulfide Topical Suspension USP, 2.5% (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.

This product should not be used by patients allergic to any of its components.

Accidental Oral Ingestion- Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is intended for external use only. There have been no documented reports of serious toxicity in humans resulting from acute ingestion of Selenium Sulfide Topical Suspension USP, 2.5% (Lotion); however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. For this reason, evacuation of the stomach contents should be considered in cases of acute oral ingestion.