Label: PHYTOVET PSS- benzoyl peroxide, sodium thiosulfate, salicylic acid, phytosphingosine hydrochloride shampoo

  • NDC Code(s): 11695-7207-1, 11695-7207-2
  • Packager: Henry Schein Animal Health
  • Category: OTC ANIMAL 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.

Drug Label Information

Updated April 5, 2017

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    PHYTOVET PSS

    ANTISEBORHEIC SHAMPOO

    Active Ingredients: benzoyl peroxide 3%, salicylic acid 2%, sodium thiosulfate 2%, phytosphingosine HCI 0.05%.

    Inactive Ingredients: water, sodium C14-16 olefin sulfonate, propylene glycol, acrylates copolymer, myristamine oxide, sodium dioctyl sulfosuccinate, fragrance, tocopheryl acetate, methylchloroisothiazolinone, methylisothiazolinone.

    Properties: PhytoVet PSS Antiseborrheic Shampoo is a cleansing and degreasing, soap-free shampoo for the relief of scaling and itching associated with skin infections, seborrheic disorders, and follicular plugging on dogs, cats and horses. The combination of benzoyl peroxide, micronized sulfur and salicylic acid allows for degreasing, follicular flushing, and enhanced keratolytic and keratoplastic activity. PhytoVet PSS Antiseborrheic Shampoo contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier. Active ingredients in this shampoo also have antimicrobial properties.

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  • INDICATIONS & USAGE

    Indications: For use on dogs, cats and horses only. For the management of skin infections and seborrheic disorders.

    Directions for Use: Wet the animal with cool water and massage the shampoo first on the areas with skin abnormalities, then on the rest of the body. Leave the shampoo on for 10 minutes then rinse with cool water. Use 2-3 times per week until symptoms subside or as directed by your veterinarian.

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  • WARNINGS AND PRECAUTIONS

    Cautions: For external use on dogs, cats and horses only. Avoid contact with the eyes. In the case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

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  • STORAGE AND HANDLING

    Storage Conditions: Store at room temperature. Do not freeze.

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  • SPL UNCLASSIFIED SECTION

    Questions? (855) 724-3461

    May bleach colored fabrics.

    Distributed by:
    Henry Schein Animal Health
    Dublin, OH 43017
    www.henryscheinvet.com

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  • PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

    HENRY SCHEIN®

    ANIMAL HEALTH

    NDC 11695-7207-1

    PHYTOVET PSS

    ANTISEBORRHEIC SHAMPOO

    Benzoyl Peroxide 3%, Salicylic Acid 2%,

    Sodium Thiosulfate 2%, Phytosphingosine HCl 0.05%

    Antiseborrheic and antiseptic shampoo for dogs,
    cats and horses

    Net Contents: 8 fl oz (237 mL)

    FOR VETERINARY USE ONLY

    KEEP OUT OF THE REACH OF CHILDREN

    8 ounce bottle label

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  • PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

    ´╗┐HENRY SCHEIN®

    ANIMAL HEALTH

    NDC 11695-7207-2

    PHYTOVET PSS

    ANTISEBORRHEIC SHAMPOO

    Benzoyl Peroxide 3%, Salicylic Acid 2%,
    Sodium Thiosulfate 2%, Phytosphingosine HCl 0.05%

    Antiseborrheic and antiseptic shampoo for dogs,
    cats and horses

    Net Contents: 16 fl oz (473 mL)

    FOR VETERINARY USE ONLY

    KEEP OUT OF THE REACH OF CHILDREN

    16 once bottle label

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  • INGREDIENTS AND APPEARANCE
    PHYTOVET  PSS
    benzoyl peroxide, sodium thiosulfate, salicylic acid, phytosphingosine hydrochloride shampoo
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7207
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 30 mg  in 1 mL
    SODIUM THIOSULFATE (UNII: HX1032V43M) (THIOSULFATE ION - UNII:LLT6XV39PY) SODIUM THIOSULFATE 20 mg  in 1 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg  in 1 mL
    PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    DI-N-OCTYL SODIUM SULFOSUCCINATE (UNII: 4YLY5570Y0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11695-7207-1 237 mL in 1 BOTTLE, PLASTIC
    2 NDC:11695-7207-2 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/01/2017
    Labeler - Henry Schein Animal Health (017880659)
    Registrant - Ceva Sante Animale (261126049)
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