SELENIUM SULFIDE: 545 Adverse Event Reports & Safety Profile

DESCRIPTION: Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5mg selenium sulfide, ammonium lauryl sulfate, caprylic/capric triglyceride, chromium oxide green, citric acid, cocamidopropyl betaine, D&C yellow No. 8, diazolidinyl urea, distearyl phthalic acid amide, edetate disodium, FD&C red No. 40, fragrance, hydroxypropyl methylcellulose, magnesium aluminum silicate, methylparaben, panthenol, PPG-2 hydroxyethyl coco/isostearamide, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide, tocopheryl acetate, urea and zinc pyrithione.

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

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

CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

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. To report a serious adverse event, please contact Westminster Pharmaceuticals at 1-844-221-7294 or call FDA at 1-800-FDA-1088 or fda.gov/medwatch.

Warnings For external use only. Ask a doctor before use you have seborrheic dermatitis in areas other than the scalp. When using this Product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. For use on color treated or permed hair, rinse thoroughly. Stop use and ask a doctor if Condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

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.

Active ingredient Selenium Sulfide, micronized 0,6 %

WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE DIMETHICONOL SODIUM CHLORIDE DIAMINOPYRIMIDINE OXIDE SODIUM LAURYL SULFATE SODIUM SALICYLATE GLYCERIN PHENOXYETHANOL GLYCOL DISTEARATE SODIUM BENZOATE FRAGRANCE FRESH CITRUS FLORAL ORC1501495 SODIUM METHYL COCOYL TAURATE HYDROGENATED CASTOR OIL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE ZINC PCA CITRIC ACID LAURETH-3 DICHLOROBENZYL ALCOHOL SULFUR GLYCOL STEARATE LAURIC ACID ETHYLHEXYLGLYCERIN PLATYCLADUS ORIENTALIS LEAF AVENA SATIVA (OAT) KERNEL OIL CENTELLA ASIATICA LIMOSILACTOBACILLUS FERMENTUM CAMELLIA SINENSIS LEAF PORTULACA OLERACEA WHOLE SOPHORA FLAVESCENS WHOLE MACADAMIA INTEGRIFOLIA SEED OIL ZINGIBER OFFICINALE (GINGER) ROOT OIL ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL PRINSEPIA UTILIS SEED CERAMIDE NP RHINACANTHUS NASUTUS WHOLE