Label: SKINGUARD CLEAR- benzoyl peroxide, precipitated sulfur, salicylic acid, phytosphingosine hydrochloride shampoo

  • 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 March 27, 2018

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

  • DESCRIPTION

    SkinGuard® Clear Shampoo

    Soap-free medicated shampoo with antimicrobial properties helps treat oily, greasy and flaky skin

    ACTIVE INGREDIENTS: Benzoyl Peroxide 3%, Salicylic Acid 2%, Precipitated Sulfur 2%, Phytosphingosine HCl 0.05%.

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

    PROPERTIES: SkinGuard® Clear is a cleansing, degreasing, soap-free shampoo for greasy seborrhea and hair follicle conditions. The combination of benzoyl peroxide, precipitated sulfur, and salicylic acid helps remove excessive oil, scales, and crust. SkinGuard® Clear also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

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  • INDICATIONS & USAGE

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

    DIRECTIONS FOR USE: Bathe 1-2 times per week for 2-3 weeks, or as directed by your veterinarian.  Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities.  Starting with a quarter-size amount of product, massage into the fur to reach the skin.  Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water until the water runs clear. 

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  • WARNINGS AND PRECAUTIONS

    CAUTIONS: For external use only, avoid contact with the eyes. If eye contact occurs, 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.

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  • SPL UNCLASSIFIED SECTION

    Distributed by Vicar Operating, Inc.

    Los Angeles, CA 90064

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

    clear

    Benzoyl Peroxide 3%, Salicylic Acid 2%,

    Precipitated Sulfur 2%, Phytosphingosine HCl 0.05%

    Soap-free medicated shampoo with antimicrobial properties helps treat oily, greasy and flaky skin

    VETHICAL®

    SkinGuard®

    WITH PHYTOSPHINGOSINE

    8 FL. OZ. (237 mL)

    8 ounce bottle label front

    8 ounce bottle label front

    8 ounce bottle label back

    8 ounce bottle label front

    8 ounce bottle label back

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  • INGREDIENTS AND APPEARANCE
    SKINGUARD  CLEAR
    benzoyl peroxide, precipitated sulfur, salicylic acid, phytosphingosine hydrochloride shampoo
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1411
    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:50386-1411-1 237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/27/2018
    Labeler - VICAR OPERATING INC (052503799)
    Registrant - Ceva Sante Animale (261126049)
    Establishment
    Name Address ID/FEI Business Operations
    Vantage Specialty Ingredients, Inc. 061709127 api manufacture
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