VITAL-BENZ (BENZOYL PEROXIDE, SULFUR AND SALICYLIC ACID) SHAMPOO [VITAL ANIMAL HEALTH]

VITAL-BENZ (BENZOYL PEROXIDE, SULFUR AND SALICYLIC ACID) SHAMPOO [VITAL ANIMAL HEALTH]
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NDC 60255-335-16, 60255-335-28
Set ID 4603e989-0d50-4bfc-8b8b-76d87ac4ea45
Category OTC ANIMAL DRUG LABEL
Packager Vital Animal Health
Generic Name
Product Class
Product Number
Application Number
  • 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

    image of label

  • INGREDIENTS AND APPEARANCE
    VITAL-BENZ 
    benzoyl peroxide, sulfur and salicylic acid shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:60255-335
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE30 mg  in 1 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR20 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60255-335-16474 mL in 1 BOTTLE, PLASTIC
    2NDC:60255-335-283785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/31/2013
    Labeler - Vital Animal Health (003927150)
    Registrant - Custom Veterinary Services, Inc. (619511483)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Veterinary Services, Inc619511483manufacture, api manufacture

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