Label: SELENIUM SULFIDE shampoo

  • NDC Code(s): 42192-152-06
  • Packager: Acella Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 12, 2018

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  • DESCRIPTION

    ​DESCRIPTION: A 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.

  • CLINICAL PHARMACOLOGY

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

  • PHARMACOKINETICS

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

  • INDICATIONS & USAGE

    INDICATIONS & USAGE: A 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.

  • CONTRAINDICATIONS

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

  • WARNINGS

    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.

  • PRECAUTIONS

    PRECAUTIONS: This medication is to be used as directed by a 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 C

    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 2.25% 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 a nursing woman.

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

  • ADVERSE REACTIONS

    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.

  • OVERDOSAGE

    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.

  • 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

    HOW SUPPLIED: Selenium Sulfide 2.25% Shampoo is supplied in 6 fluid oz. (180 mL) bottles, NDC 42192-152-06. 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. 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 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

    Manufactured for:
    Acella Pharmaceuticals, LLC
    Alpharetta, GA 30022
    Rev 0417-01

  • Principal Display Panel -180 mL Bottle

    NDC 42192-152-06

    ​Rx Only

    Selenium

    Sulfide

    2.25%

    Shampoo

    ​6 fluid oz. (180 mL)

    FOR TOPICAL USE ONLY

    NOT FOR OPTHALMIC USE

    Bottle Label

    Base Label

  • INGREDIENTS AND APPEARANCE
    SELENIUM SULFIDE 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42192-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE22.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PPG-2 HYDROXYETHYL ISOSTEARAMIDE (UNII: 083X27325R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    PYRITHIONE ZINC (UNII: R953O2RHZ5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-152-061 in 1 CARTON07/12/2017
    1180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/12/2017
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939manufacture(42192-152)