Label: VITAL-SALITAR - salicylic acid, menthol and coal tar shampoo

  • NDC Code(s): 60255-337-16, 60255-337-28
  • Packager: Vital Animal Health
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each dosage unit)       Purpose

    Salicylic Acid 3% (w/w) ................................ keratolytic

    Coal Tar Solution 2% (w/w) .......................... antiseborrheic

    Menthol 1% (w/w) ........................................ antipruritic

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  • PURPOSE

    Uses

    An antiseborrheic, mentholated, keratolytic, soap-free formulation with a unique combination of surfactants and coat conditioners. For relief of irritation, itching and skin flaking associated with seborrhea and nonspecific dermatoses.

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  • WARNINGS AND PRECAUTIONS

    Warnings
    DO NOT USE ON CATS • For Animal Use Only • Keep out of reach of children • Wash hands after use • For topical use in dogs and horses • Avoid contact with eyes or mucous membranes • Not for otic use • If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

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  • DOSAGE & ADMINISTRATION

    Directions
    Shake well before use. Wet coat thoroughly. Apply and lather Vital-SaliTar Shampoo over the entire body, allowing for 5 to 10 minutes of contact time. Rinse completely. Repeat procedure if necessary. Use once or twice weekly, or as directed by your veterinarian.

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  • STORAGE AND HANDLING

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

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  • SPL UNCLASSIFIED SECTION

    Vital-SaliTar Shampoo

    NOT FOR SALE IN CALIFORNIA

    Vital Animal Health
    www.vitalanimalhealth.com


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

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  • PRINCIPAL DISPLAY PANEL

    Vital-SaliTar
    Shampoo

    for dogs and horses
    Salicylic Acid 3%, Coal Tar Solution 2%, Menthol 1%

    An antiseborrheic, keratolytic and antipruritic conditioning shampoo for dogs

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

    MADE IN THE USA


    image of label

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  • INGREDIENTS AND APPEARANCE
    VITAL-SALITAR 
    salicylic acid, coal tar, menthol shampoo
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:60255-337
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 30 mg  in 1 mL
    MENTHOL (MENTHOL) MENTHOL 10 mg  in 1 mL
    COAL TAR (COAL TAR) COAL TAR 20 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60255-337-16 474 mL in 1 BOTTLE, PLASTIC
    2 NDC:60255-337-28 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
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