Label: OXIDERM PS- benzoyl peroxide, sodium thiosulfate, salicylic acid, phytosphingosine shampoo

  • NDC Code(s): 13744-118-01, 13744-118-02, 13744-118-03
  • Packager: Ceva Sante Animale
  • 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 February 18, 2016

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

  • DESCRIPTION

    Oxiderm +PS

    Shampoo

    ACTIVE INGREDIENTS: Benzoyl Peroxide 3%, Salicylic Acid 2%, Sodium Thiosulfate 2%, Phytosphingosine HCl 0.05%.

    INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, Acrylates Copolymer, Propylene Glycol, Myristamine Oxide, Sodium Dioctyl Sulfosuccinate, Fragrance, Tocopheryl Acetate.

    PROPERTIES: Oxiderm +PS 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 and cats. The combination of benzoyl peroxide, micronized sulfur and salicylic acid allows for degreasing, follicular flushing, and enhanced keratolytic and keratoplastic activity. Oxiderm +PS Shampoo contains phytosphingosine, a Ceva exclusive pro-ceramide to help support a healthy skin barrier. Actives in this shampoo also have antimicrobial properties.

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  • INDICATIONS & USAGE

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

    DIRECTIONS FOR USE: Wet the animal with warm water and apply Oxiderm +PS Shampoo. Massage into the wet hair coat. Allow to remain on the hair coat for 5 to 10 minutes before rinsing thoroughly with clean water. Repeat if needed. Apply 3 times per week or as directed by your veterinarian. May be part of a management plan as recommended by your veterinarian.

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  • WARNINGS AND PRECAUTIONS

    CAUTIONS: For external use on dogs and cats 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.

    WARNING: Keep out of the reach of children.

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  • STORAGE AND HANDLING

    STORAGE CONDITIONS: Store at room temperature. Do not freeze.

    Authorized for sale through licensed veterinarians only.

    May bleach colored fabrics. 

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  • SPL UNCLASSIFIED SECTION

    Manufactured for Ceva Animal Health, LLC

    Lenexa, KS 66215 ¦ 1-800-999-0297

    ©2015 Ceva Animal Health, LLC

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

    Oxiderm +PS

    Shampoo

    Benzoyl Peroxide 3%, Salicylic Acid 2%,

    Sodium Thiosulfate 2%, Phytosphingosine HCl 0.05%

    Antiseborrheic and Antiseptic Shampoo

    Phytosphingosine

    8 FL. OZ. (237 mL)

    Ceva

    8 ounce bottle label

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

    Oxiderm+PS

    Shampoo

    Benzoyl Peroxide 3%, Salicylic Acid 2%,

    Sodium Thiosulfate 2%, Phytosphingosine HCl 0.05%

    Antiseborrheic and Antiseptic Shampoo

    Phytosphingosine

    16 FL. OZ. (473 mL)

    Ceva

    16 once bottle label

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  • PRINCIPAL DISPLAY PANEL - 1 Gallon Jug

    Oxiderm+PS

    Shampoo

    Benzoyl Peroxide 3%, Salicylic Acid 2%,

    Sodium Thiosulfate 2%, Phytosphingosine HCl 0.05%

    Antiseborrheic and Antiseptic Shampoo

    Phytosphingosine

    1 Gallon

    Ceva

    1 Gallon Jug label

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  • INGREDIENTS AND APPEARANCE
    OXIDERM PS 
    benzoyl peroxide, sodium thiosulfate, salicylic acid, phytosphingosine shampoo
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13744-118
    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)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13744-118-01 237 mL in 1 BOTTLE, PLASTIC
    2 NDC:13744-118-02 473 mL in 1 BOTTLE, PLASTIC
    3 NDC:13744-118-03 3785 mL in 1 JUG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2016
    Labeler - Ceva Sante Animale (261126049)
    Registrant - Ceva Sante Animale (261126049)
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