Label: SELENIUM SULFIDE shampoo
- NDC Code(s): 16477-423-06
- Packager: Laser Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated September 13, 2022
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- SPL UNCLASSIFIED SECTION
DESCRIPTION: A liquid antiseborrheic, antifungal preparation for topical application. Each mL of Selenium Sulfide 2.3% Shampoo contains 23.0 mg selenium sulfide, and the following inactive ingredients: butylated hydroxytoluene, cetyl alcohol, citric acid, cocamidopropyl betaine, disodium EDTA, D&C Yellow #10, FD&C Red #40, fragrance, panthenol, phenoxyethanol, propylene glycol, purified water, strearyl alcohol, sodium laureth sulfate, sodium thiosulfate, tocopheryl acetate, triacetin, urea, xanthan gum.
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
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.
USE IN PREGNANCY
USE IN PREGNANCY:
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 a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, selenium sulfide 2.3% shampoo should not be used by pregnant women.
- NURSING MOTHERS
- PEDIATRIC USE
- ADVERSE REACTIONS
OVERDOSAGE: There are no documented reports of serious toxicity in humans resulting from acute ingestion of selenium sulfide 2.3%
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 & ADMINISTRATION
DOSAGE AND ADMINISTRATION:
SHAKE WELL BEFORE USING
For seborrheic dermatitis and dandruff: Generally 2 applications each week for 2 weeks will control symptoms. Subsequently, shampoo may be used less frequently – weekly, every 2 weeks, every 3 to 4 weeks or as directed by a 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 a full lather. Allow product to remain on
skin for 10 minutes, then rinse thoroughly. Repeat procedure once a day for seven days or as directed by a physician.
HOW SUPPLIED: Selenium Sulfide 2.3% Shampoo is supplied in 6 fluid oz. (180 mL) bottles, NDC 16477-423-06. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 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: The product may darken upon storage. Discoloration does not impair the efficacy or safety of the product. Keep container tightly closed. 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 other equivalency testing. No representation is made as to generic status or bioequivalency.
Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, inactive ingredients (excipients) and other chemical information provided herein.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
selenium sulfide shampoo
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16477-423 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 23 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM THIOSULFATE (UNII: HX1032V43M) XANTHAN GUM (UNII: TTV12P4NEE) UREA (UNII: 8W8T17847W) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) FD&C RED NO. 40 (UNII: WZB9127XOA) PANTHENOL (UNII: WV9CM0O67Z) CETYL ALCOHOL (UNII: 936JST6JCN) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TRIACETIN (UNII: XHX3C3X673) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16477-423-06 180 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/02/2020 Labeler - Laser Pharmaceuticals, LLC (614417132)