Label: UNIVERSAL MEDICATED- chloroxylenol, salicylic acid, and sodium thiosulfate shampoo

  • NDC Code(s): 17030-016-10, 17030-016-16
  • Packager: Vetoquinol USA, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 12, 2018

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

  • VETERINARY INDICATIONS

    Universal Medicated Shampoo may be used as adjunctive therapy for the most common dermatological conditions.

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  • SPL UNCLASSIFIED SECTION

    ACTIVE INGREDIENTS:

    Chloroxylenol 2%, Salicylic Acid 2%, Sodium Thiosulfate 2% (source of soluble sulfur).

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  • SPL UNCLASSIFIED SECTION

    INACTIVE INGREDIENTS:

    USP Purified Water, Sodium Olefin Sulfonate, Propylene Glycol, Cocamidopropyl Betaine, Polyquaternium-10, Sodium Hydroxide, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid and FD&C Blue #1.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    Shake well. With tepid water, thoroughly wet animal's coat. Massage small amounts of shampoo into the coat while continuously adding water to get better dispersion. Continue until a generous lather is generated. Rinse well and repeat procedure. Shampoo may be used weekly or as often as recommended by your veterinarian.

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  • SPL UNCLASSIFIED SECTION

    CAUTIONS:

    Keep out of the reach of children. For topical use only. Avoid contact with eyes. If eye contact occurs, immediately flush with water.

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  • STORAGE AND HANDLING

    STORAGE:

    Store at controlled room temperature.

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  • SPL UNCLASSIFIED SECTION

    QUESTIONS?

    Manufactured for:
    Vetoquinol USA, Inc.
    Ft. Worth, TX (USA) 76137
    1 (800) 267-5707
    www.vetoquinolusa.com

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  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 17030-016-16

    vetoquinoL

    UNIVERSAL
    MEDICATED
    SHAMPOO

    Deep Cleansing, Antimicrobial

    2% Chloroxylenol, 2% Salicylic Acid, 2% Sodium Thiosulfate.
    Antimicrobial, Antifungal and Deodorizing.

    YEAST/
    BACTERIA
    ANTIFUNGAL
    DRY/FLAKY
    OILY/FLAKY

    NET CONTENTS: 16 fl oz (473mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    UNIVERSAL MEDICATED 
    chloroxylenol, salicylic acid, and sodium thiosulfate shampoo
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17030-016
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol 20 mg  in 1 mL
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 20 mg  in 1 mL
    Sodium Thiosulfate (UNII: HX1032V43M) (Thiosulfate Ion - UNII:LLT6XV39PY) Sodium Thiosulfate 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Polyquaternium-10 (125 MPA.S at 2%) (UNII: L45WU8S981)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17030-016-16 473 mL in 1 BOTTLE, PLASTIC
    2 NDC:17030-016-10 3790 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 04/17/2017
    Labeler - Vetoquinol USA, Inc. (106824209)
    Establishment
    Name Address ID/FEI Business Operations
    American Pharmaceuticals and Cosmetics, Inc. 038023805 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    N.S.Chemicals 650469732 API MANUFACTURE
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