BIOSEB MOUSSE- salicylic acid shampoo

BioSeb by

Drug Labeling and Warnings

BioSeb by is a Animal medication manufactured, distributed, or labeled by VetBiotek, Inc., Custom Veterinary Services, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BIOSEB  MOUSSE
salicylic acid shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86056-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86056-021-07	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/10/2016

Labeler - VetBiotek, Inc. (079730642)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Veterinary Services, Inc.		619511483	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Rhodia Poliamida e Especialidades Ltda.		902300545	api manufacture