Label: SELENIUM SULFIDE shampoo
- NDC Code(s): 69367-229-18
- Packager: Westminster Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated January 4, 2023
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- Official Label (Printer Friendly)
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DESCRIPTION
Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5mg selenium sulfide, and the following inactive ingredients: butylated hydroxytoluene, cetyl alcohol, citric acid, cocamidopropyl betaine, disodium EDTA, D&C yellow No. 10, FD&C red No. 40, fragrance, panthenol, phenoxyethanol, propylene glycol, purified water, pyrithione zinc, sodium laureth sulfate, sodium thiosulfate, stearyl alcohol, tocopherol acetate, triacetin, urea, xanthan gum.
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- CONTRAINDICATIONS
- WARNINGS
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PRECAUTIONS
General
This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.
Information for Patients
Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. If accidental contact occurs, rinse thoroughly with water. Do not use on broken skin or inflamed areas.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects. Studies on reproduction and fertility also have not been performed.
Pregnancy
CATEGORY C
Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. Under ordinary circumstances, selenium sulfide 2.25% shampoo should not be used by pregnant women.
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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.
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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.
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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.
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STORAGE
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.
NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SELENIUM SULFIDE
selenium sulfide shampooProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-229 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 22.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) PYRITHIONE ZINC (UNII: R953O2RHZ5) UREA (UNII: 8W8T17847W) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM THIOSULFATE (UNII: HX1032V43M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TRIACETIN (UNII: XHX3C3X673) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69367-229-18 180 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 09/09/2019 Labeler - Westminster Pharmaceuticals, LLC (079516651)
