SELENIUM SULFIDE

Rochester Pharmaceuticals

FULL PRESCRIBING INFORMATION: CONTENTS*

• SELENIUM SULFIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS
• INDICATIONS & USAGE
• SELENIUM SULFIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• CARCINOGENESIS
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• SELENIUM SULFIDE ADVERSE REACTIONS
• OVERDOSAGE
• SELENIUM SULFIDE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Package Label

FULL PRESCRIBING INFORMATION

SELENIUM SULFIDE DESCRIPTION

CLINICAL PHARMACOLOGY

Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production.

PHARMACOKINETICS

The mechanism of action of topically applied selenium sulfide is not yet known.

INDICATIONS & USAGE

A liquid antiseborrheic, antifungal preparation for the treatment of seborrheic dermatitis of the scalp, dandruff and tinea versicolor. Urea hydrates and is useful for conditions such as dry scalp.

SELENIUM SULFIDE CONTRAINDICATIONS

Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.

WARNINGS

For external use only. Not for ophthalmic use. DO NOT USE ON BROKEN SKIN OR INFLAMED AREAS. If allergic reaction occurs, discontinue use. Avoid contact with eyes, genital areas and
skin folds, as irritation and burning may result. If accidental contact occurs, rinse thoroughly with water.

PRECAUTIONS

This medication is to be used as directed by a physician. Not to be used when inflammation or exudation is present as increased absorption may occur.

CARCINOGENESIS

Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects.

PREGNANCY

CATEGORY C. Animal reproduction studies have not been conducted with this medication. It is also not known whether this product can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, selenium sulfide 2.25% shampoo should not be used by pregnant women.

NURSING MOTHERS

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when this product is administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in children have not been established.

SELENIUM SULFIDE ADVERSE REACTIONS

In decreasing order of severity: skin irritation; occasional reports of increase in 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.

OVERDOSAGE

There are no documented reports of serious toxicity in humans resulting from acute ingestion of selenium sulfide 2.25% shampoo.  However, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. Evacuation of the stomach contents should be considered in cases of acute oral ingestion.

SELENIUM SULFIDE DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Selenium Sulfide 2.25% Shampoo is supplied in 180 mL bottles, NDC 49908-146-80.

Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized. Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:
Rochester Pharmaceuticals
Rochester, NY 14624
1-866-458-1772
www.RochesterPharm.com

SSS-PI-0912

Package Label