Label: TERSI- selenium sulfide aerosol, foam

  • Category: NON-STANDARDIZED ALLERGENIC LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated December 4, 2009

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  • SPL UNCLASSIFIED SECTION

    TERSI Hydrating Topical Foam

    (selenium sulfide in a water and lipid based foam, 2.25%)


    Rx Only
  • DESCRIPTION

    TERSI, which is applied topically, is an antiseborrheic, antifungal preparation for the treatment of seborrheic dermatitis and tinea versicolor of the skin. Each gram of TERSI contains selenium sulfide 2.25% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, stearic acid, trolamine, and in propellants butane and propane. 

    CHEMICAL STRUCTURE

    Selenium sulfide has the following chemical structure:

    chemical-structure

  • CLINICAL PHARMACOLOGY

    Topically applied selenium sulfide appears to have a cytostatic effect on cells of the epidermis, reducing corneocyte production.

    PHARMACOKINETICS

    The mechanism of action of topically applied selenium sulfide is not yet known. 
  • INDICATIONS AND USAGE

    For the treatment of seborrheic dermatitis and tinea versicolor of the skin.
  • CONTRAINDICATIONS

    Known hypersensitivity to any of the listed ingredients.
  • WARNINGS

    TERSI is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips, broken or inflamed skin, and all mucous membranes should be avoided. TERSI should not be used by persons who have a known hypersensitivity to selenium sulfide or any of the other listed ingredients. 
  • PRECAUTIONS

    TERSI should be used only as directed by a physician and should not be used to treat any condition other than that for which it is prescribed.TERSI should not be used on any skin area where inflammation or exudation is present as increased absorption may occur. If redness or irritation occurs, discontinue use and consult with prescribing physician.

    Pregnancy (Category C)

    Animal reproduction studies have not been performed with topically applied selenium sulfide and it is not known whether TERSI can cause fetal harm when administered to a pregnant woman. Nevertheless, TERSI should be used by a pregnant woman only if necessary. 

    Nursing Mothers

    It is not known whether topically applied selenium sulfide is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering TERSI to nursing mothers. 
    KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • ADVERSE REACTIONS

    Transient stinging, burning, itching or irritation is possible.
  • DOSAGE AND ADMINISTRATION

    Unless otherwise directed by a prescribing physician,TERSI should be applied to affected area twice a day.TERSI should be rubbed into the skin until it is completely absorbed.

    TERSI should be shaken vigorously before each application and inverted to administer.

    canister-inverted

  • HOW SUPPLIED

    TERSI is supplied in a 70 gram or 2.5 ounce aerosolized canister bearing the NDC Number 23710-225-70 and a 10 gram or 0.36 ounce aerosolized canister bearing the NDC Number 23710-025-01. The 10 gram canister is physician dispensed sample product.

    Store at controlled room temperature 15º - 25ºC (59º - 77ºF).

    Contains flammable materials. Contents under pressure. Do not puncture or incinerate. Do not expose to temperatures over 120ºF [48ºC] even when empty. Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    TERSI is covered by U.S. Patent 5,993,830.

    TERSI is manufactured for Quinnova Pharmaceuticals, Inc., Newtown, PA 18940, (877) 660­6263, www.QUINNOVA.com.

    Prescribing Information as of September2007.

    company-logo

    TRSFO025 7/08

  • Can Label

    canister-label
  • Folding Carton

    Folding-Carton
  • INGREDIENTS AND APPEARANCE
    TERSI 
    selenium sulfide aerosol, foam
    Product Information
    Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:23710-225
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE1.44 g  in 70 g
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23710-225-7070 g in 1 CANISTER
    2NDC:23710-225-0110 g in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER12/01/2009
    Labeler - Quinnova Pharmaceuticals, Inc. (607183766)
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