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.

  • SPL UNCLASSIFIED SECTION

    ACTIVE INGREDIENTS:

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

  • 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.

  • 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.

  • 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.

  • STORAGE AND HANDLING

    STORAGE:

    Store at controlled room temperature.

  • SPL UNCLASSIFIED SECTION

    QUESTIONS?

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

  • 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
  • INGREDIENTS AND APPEARANCE
    UNIVERSAL MEDICATED 
    chloroxylenol, salicylic acid, and sodium thiosulfate shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17030-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol20 mg  in 1 mL
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
    Sodium Thiosulfate (UNII: HX1032V43M) (Thiosulfate Ion - UNII:LLT6XV39PY) Sodium Thiosulfate20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17030-016-16473 mL in 1 BOTTLE, PLASTIC
    2NDC:17030-016-103790 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/17/2017
    Labeler - Vetoquinol USA, Inc. (106824209)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Pharmaceuticals and Cosmetics, Inc.038023805MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    N.S.Chemicals650469732API MANUFACTURE