selenium sulfide (SELENIUM SULFIDE)  lotion 
[Perrigo New York, Inc.]

NDC 45802-040-64

Rx only

FOR EXTERNAL USE ONLY
SHAKE WELL BEFORE USE

Store at controlled room temperature 15°-30° C (59° - 86°F).

Lot No. & Exp. Date: See label or bottom of container.

DESCRIPTION

A liquid antiseborrheic, antifungal preparation for topical application. Selenium Sulfide has the formula SeS2 and has a molecular weight of 143.08.

CONTAINS

Selenium Sulfide 2.5%, Purified Water, Sodium Lauryl Sulfate, Ethylene Glycol Monostearate, Titanium Dioxide, Cocoamphocarboxyglycinate, Lauramide DEA, Bentonite, Sodium Phosphate (monobasic), Glyceryl Monoricinoleate, Fragrance, Citric Acid.

CLINICAL PHARMACOLOGY

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

INDICATION AND USAGE

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

CONTRAINDICATIONS

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

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.

ADVERSE REACTIONS

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.

OVERDOSAGE

Accidental Oral Ingestion

Selenium Sulfide 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 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.

DOSAGE AND ADMINISTRATION

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 lotion 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 7 days.

HOW SUPPLIED

Selenium Sulfide Lotion, USP 2.5% is available in 4 fl oz plastic bottles.

Mfg. By: CLAY-PARK LABS, INC., Bronx, NY 10457

LCPL04054-2B   R0504

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 teaspoonfuls of shampoo 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 7 days.

WARNINGS AND PRECAUTIONS:

For External Use Only. Do not use on broken skin or infected 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.

Mfg. By: CLAY-PARK LABS, INC., Bronx, NY 10457

R04DS4CPL-2B

SELENIUM SULFIDE (SELENIUM SULFIDE)

PRODUCT INFO Product Code 45802-040 Dosage Form LOTION Route Of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength SELENIUM SULFIDE (Selenium sulfide) Active 25 MILLIGRAM  In 1 MILLILITER Bentonite Inactive   Citric Acid Inactive   Cocoamphocarboxyglycinate Inactive   Ethylene glycol monstearate Inactive   Fragrance Inactive   Glyceryl Monoricinioleate Inactive   Lauramide DEA Inactive   Water Inactive   Sodium Phosphate (monobasic) Inactive   Sodium Lauryl Sulfate Inactive   Titanium Dioxide Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 45802-040-64 118 MILLILITER In 1 BOTTLE None

Revised: 01/2007