VITAL-BENZ- benzoyl peroxide, sulfur and salicylic acid shampoo

Vital-Benz by

Drug Labeling and Warnings

Vital-Benz by is a Animal medication manufactured, distributed, or labeled by Vital Animal Health, Custom Veterinary Services, Inc., Custom Veterinary Services, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each dosage unit)     Purpose

Benzoyl Peroxide 3% (w/w) ......................... antobacterial

Sulfur 2% (w/w) .......................................... antiseborrheic

Salicylic Acid 2% (w/w) ............................... keratolytic

PURPOSE

Uses
A powerful cleansing and degreasing shampoo for the relief of scaling and itching associated with skin infection, seborrheic disorders, and follicular plugging on dogs, cats, and horses. The combination of benzoyl peroxide, micronized sulfur and salicylic acid allows for degreasing, follicular flushing, and enhanced keratolytic and keratoplastic activity. The combination also has antiseptic (antibacterial and antifungal) properties. Vital-Benz Shampoo is formulated in a pleasantly scented soap-free, lathering shampoo base with skin moisturizers for gentle cleaning and deodorizing, while effectively removing scales and oils from the coat.

WARNINGS AND PRECAUTIONS

Warnings
For Animal Use Only For topical use in dogs, cats and horses Avoid contact with eyes or mucous membranes If contact occurs, rinse thoroughly with water and consult a veterinarian MAY BLEACH COLORED FABRICS Keep out of reach of children If undue skin irritation develops or increases, discontinue use and consult a veterinarian

DOSAGE & ADMINISTRATION

Directions
Shake well before use. Wet the hair coat with warm water. Apply and lather Vital-Benz Shampoo first on the affected area then apply and lather on the entire hair coat. Allow to remain on hair for 5 to 10 minutes then rinse thoroughly with clean water. Repeat if necessary. May be used 2 to 3 times per week or as directed by your veterinarian.

STORAGE AND HANDLING

Other Information
Store at room temperature (59˚F - 86˚F)
Available only through licensed veterinarians.

SPL UNCLASSIFIED SECTION

Vital-Benz Shampoo

Vital Animal Health
www.vitalanimalhealth.com


Manufactured in USA for:
Vital Animal Health
2031 Rand Ave.
Colorado Springs, CO 80905
800-344-1165

PRINCIPAL DISPLAY PANEL

Vital-Benz
Shampoo

for dogs, cats and horses
Benzoyl Peroxide 3%, Sulfur 2%, Salicylic Acid 2%

Antiseborrheic, antiseptic and keratolytic shampoo in a moisturizing and soap-free cleansing base
Powerful cleansing and degreasing shampoo

16 FL OZ (474 ML)   or  1 GALLON (3.78 L)

MADE IN THE USA

INGREDIENTS AND APPEARANCE

VITAL-BENZ 
benzoyl peroxide, sulfur and salicylic acid shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 60255-335
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
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	20 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60255-335-16	474 mL in 1 BOTTLE, PLASTIC
2	NDC: 60255-335-28	3785 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/31/2013

Labeler - Vital Animal Health (003927150)

Registrant - Custom Veterinary Services, Inc. (619511483)

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