APPLICATION INSTRUCTIONS
Keep tightly capped. SHAKE WELL BEFORE USING.
Product may damage jewelry; remove jewelry before use.
For treatment of dandruff and seborrheic dermatitis of the scalp:
1. Massage about 1 or 2 teaspoonsful of suspension into wet scalp.
2. Allow to remain on scalp for 2 to 3 minutes.
3. Rinse scalp thoroughly.
4. Repeat application and rinse thoroughly.
5. After treatment, wash hands well.
6. Repeat treatments as directed by physician.
For treatment of tinea versicolor:
1. Apply to affected areas and lather with a small amount of water.
2. Allow to remain on skin for 10 minutes.
3. Rinse body thoroughly.
4. Repeat this procedure once a day for seven days.
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 Topical Suspension USP, 2.5% (Lotion) 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 topical suspension, 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 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.
WARNINGS AND PRECAUTIONS:
For External Use Only. Do not use on broken skin or inflamed areas. If allergic reactions occur, discontinue use. Avoid getting shampoo in eyes or in contact with genital area as it may cause irritation and burning.
KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
|
