Label: BIOSEB MOUSSE- salicylic acid 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 November 12, 2021

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Salicylic Acid 2%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, Ethyl Lactate, Ordenone, Glycerin, Sodium Alpha Olefin Sulfonate, Cocamidopropyl Betaine, Fragrance, SDA40B Alcohol, Polysorbate 80, Acrylates Copolymer, Polyquaternium 7, Methylchloroisothiazolinone, Methylisothiazolinone, N-Octadecanoylphytosphingosine (Ceramide III) and MicroSilver

  • INDICATIONS & USAGE

    BioSeb Mousse: Combines a proprietary formulation of Salicylic Acid, Ethyl Lactate and MicroSilver BG for enhanced antiseptic and keratoplastic activity. Ceramide III helps support healthy skin.


    PRODUCT DESCRIPTION: BioSeb Mousse is an antiseptic keratoplastic and keratolytic mousse with an optimal skin pH balance for use on dogs, cats, and horses. Formulated for adjunctive topical management to help normalize keratinization, reduce scale formation and manage seborrhea.

    DIRECTIONS: Shake well before use. Brush the hair coat before application. For dogs and cats, dispense the volume of product onto the dry hair coat, based on weight, as indicated in the table below. Throroughly, but gently, massage into the dry hair coat to allow the product to reach the skin.  Repeat as necessary to cover the whole body of the animal. For horses, use focally on areas where application is warranted. Do not rinse off and allow to air dry.

    Use as often as necessary. Safe to use with topical flea products and other topical skin medications.

    For dogs and cats:
    Under 11 lbs . . . 1 pump per 2 lbs
    12-88 lbs . . . 1 pump per 4 lbs
    Over 89 lbs . . . 1 pump per 6 lbs
    Dosage may be doubled for long-haired dogs

    For horses: Use focally to cover the area of application.

  • GENERAL PRECAUTIONS

    PRECAUTIONS: For topical use only on dogs, cats and horses. Avoid contact with eyes and mouth. If eye contact occurs, rinse thoroughly with water, discontinue use and immediately consult a veterinarian.

  • STORAGE AND HANDLING

    STORAGE: Store at room temperature. Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    AVAILABLE THROUGH LICENSED VETERINARIANS ONLY


    MANUFACTURED FOR:
    VetBiotek Inc., Largo, Florida USA • 888-798-2030
    www.vetbiotek.com


    VBDBS0200 Rev: 01212016 CVS


    MicroSilver BG is a trademark of Bio-Gate AG

  • PRINCIPAL DISPLAY PANEL

    BioSeb Mousse

    Salicylic Acid 2%

    and Ethyl Lactate 10%

    Antiseptic, Keratoplastic and Keratolytic Mousse

    SHAKE WELL BEFORE USE

    6.8 oz. (200 mL)

    Mixrosilver BG Logo     Ceramide III Logo

    VetBiotek Innovative Solutions

    label

  • INGREDIENTS AND APPEARANCE
    BIOSEB  MOUSSE
    salicylic acid shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86056-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ETHYL LACTATE (UNII: F3P750VW8I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    SILVER (UNII: 3M4G523W1G)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86056-021-07200 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/10/2016
    Labeler - VetBiotek, Inc. (079730642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Veterinary Services, Inc.619511483manufacture, api manufacture