Label: SELENIUM SULFIDE shampoo
- NDC Code(s): 69367-229-18
- Packager: Westminster Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated December 11, 2020
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Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5mg selenium sulfide, alpha-tocopherol acetate, ammonium lauryl sulfate, butylated hydroxytoluene, cetyl alcohol, cocamidopropyl betaine, Disodium EDTA, D&C Yellow No. 10, FD&C Red No. 40, fragrance (citrus fresh), methylparaben, panthenol, propylene glycol, propylparaben, purified water, pyrithione zinc, sodium thiosulfate, stearyl alcohol, triacetin, urea, xanthan gum.
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
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.
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.
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.
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.
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.
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.
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
INGREDIENTS AND APPEARANCE
selenium sulfide shampoo
Product 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 AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) .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) METHYLPARABEN (UNII: A2I8C7HI9T) PANTHENOL (UNII: WV9CM0O67Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) 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) 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 (079516651)