NURSING MOTHERS SECTION.

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 nursing woman.

OVERDOSAGE SECTION.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

NDC 16477-422-06Rx OnlySeleniumSulfide2.25%Shampoo6 fluid oz. (180 mL)FOR TOPICAL USE ONLYNOT FOR OPTHALMIC USE. label. 2. label.

PEDIATRIC USE SECTION.

PEDIATRIC USE: Safety and effectiveness in children have not been established.

PHARMACOKINETICS SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION: liquid antiseborrheic, antifungal preparation for topical application. Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5 mg selenium sulfide, ammonium lauryl sulfate, caprylic/capric triglyceride, citric acid, cocamidopropyl betaine, chromium oxide green, FD&C yellow 8, distearyl phthalic acid amide, diazolidinyl urea, edetate disodium, fragrance, hydroxypropyl methylcellulose, magnesium aluminum silicate, methylparaben, panthenol, PPG-2 hydroxyethyl coco/isostearamide, propylene glycol, propylparaben, purified water, FD&C Red 40, sodium citrate, tocopherol acetate, titanium dioxide, urea, and zinc pyrithione.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:SHAKE WELL BEFORE USING For seborrheic dermatitis and dandruff: Generally applications each week for weeks will control symptoms. Subsequently, shampoo may be used less frequently weekly, every weeks, every to weeks or as directed by physician. Should not be applied more frequently than necessary to maintain control. For tinea versicolor: Wet skin and apply to affected areas. Massage gently into skin working to full lather. Allow product to remain on skin for 10 minutes, then rinse thoroughly. Repeat procedure once day for seven days or as directed by physician.

HOW SUPPLIED SECTION.

HOW SUPPLIED: Selenium Sulfide 2.25% Shampoo is supplied in fluid oz. (180 mL) bottles, NDC 16477-422-06. Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (between 59F and 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); however, such exposure should be minimized. Protect from freezing. All prescription substitutions and or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or otherequivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending prescription substitution using this product shall make such recommendations based on each such persons professional opinion and knowledge, upon evaluating the active ingredients, inactive ingredients (excipients) and other chemical information provided herein.

INDICATIONS & USAGE SECTION.

INDICATIONS USAGE: 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.

ADVERSE REACTIONS SECTION.

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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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.

CLINICAL PHARMACOLOGY SECTION.

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

CONTRAINDICATIONS SECTION.

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

PRECAUTIONS SECTION.

PRECAUTIONS: This medication is to be used as directed by 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. USE IN PREGNANCY:CATEGORY 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 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 nursing woman. PEDIATRIC USE: Safety and effectiveness in children have not been established.

PREGNANCY SECTION.

USE IN PREGNANCY:CATEGORY 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 pregnant woman or can affect reproduction capacity. Under ordinary circumstances, selenium sulfide 2.25% shampoo should not be used by pregnant women.

SPL UNCLASSIFIED SECTION.

NOTICE: The product may darken upon storage. Discoloration does not impair the efficacy or safety of the product. Keep container tightly closed.Manufactured for: Laser Pharmaceuticals, LLC Alpharetta, GA 30004 L-0126 Rev 0322-01.

WARNINGS SECTION.

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