VETRASEB SSB- benzoyl peroxide, precipitated sulfur, salicylic acid, phytosphingosine hydrochloride shampoo

VetraSeb by

Drug Labeling and Warnings

VetraSeb by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Ceva Sante Animale, Vantage Specialty Ingredients, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

VetraSeb™ SSB Shampoo

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

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

PROPERTIES: VetraSeb™ SSB Shampoo 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. VetraSeb™ SSB Shampoo also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier. Actives in this shampoo also have antimicrobial properties.

INDICATIONS & USAGE

INDICATION: 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.

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.

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

Distributed by: MWI

Boise, Idaho 83705

www.VetOne.net

Questions?

1-800-999-0297

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

VETone®

VetraSeb™ SSB

Shampoo

Benzoyl Peroxide 3%, Salicylic Acid 2%,

Precipitated Sulfur 2%, Phytosphingosine HCl 0.05%

Antiseborrheic and Antiseptic

Shampoo +PS for Cats and Dogs

For veterinary use only

Phytosphingosine

8 FL. OZ. (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

VETone®

VetraSeb™ SSB

Shampoo

Benzoyl Peroxide 3%, Salicylic Acid 2%,

Precipitated Sulfur 2%, Phytosphingosine HCl 0.05%

Antiseborrheic and Antiseptic

Shampoo +PS for Cats and Dogs

For veterinary use only

Phytosphingosine

16 FL. OZ. (473 mL)

INGREDIENTS AND APPEARANCE

VETRASEB  SSB
benzoyl peroxide, precipitated sulfur, salicylic acid, phytosphingosine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-935
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
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	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: 13985-935-08	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 13985-935-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/03/2019

Labeler - MWI/VetOne (019926120)

Registrant - Ceva Sante Animale (261126049)

Establishment
Name	Address	ID/FEI	Business Operations
Vantage Specialty Ingredients, Inc.		061709127	api manufacture