Label: CLOTRIMAZOLE solution/ drops

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 9, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • SPL UNCLASSIFIED SECTION

    Active Ingredient

    Clotrimazole, USP 1%

  • SPL UNCLASSIFIED SECTION

    Purpose

    Antifungal

  • Uses

    For dermatological conditions responsive to Clotrimazole.

  • Warnings

    For external use only. Not for internal use.

  • When using this product

    • Avoid contact with eyes or mucous membranes. If contact occurs, immediately flush with water.
  • Stop use and consult your veterinarian if

    • Skin irritation occurs.
  • SAFE HANDLING WARNING

    Keep out of reach of children.

  • Directions

    Clean and dry affected area. Apply a thin layer morning and evening or as directed by veterinarian. If satisfactory results are not obtained within 2 weeks, consult your veterinarian.

  • Other information

    • Store at controlled room temperature (15-30° C)
    • See bottom for Lot No. and Expiration Date.
  • Inactive Ingredients

    Propylene Glycol, SD Alcohol 40B, Chloroxylenol, Cocamidopropyl PG-Dimonium Chloride Phosphate, Benzoyl Alcohol, Citric Acid (pH adjustment), Sodium Hydroxide (pH adjustment).

  • QUESTIONS?

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

  • SPL UNCLASSIFIED SECTION

    411417 7

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

    NDC 17030-002-01

    Clotrimazole Solution

    1% CLOTRIMAZOLE

    DROPS FOR
    DOGS & CATS

    Net Contents: 1 fl oz (30 mL)

    vetoquinoL

    PRINCIPAL DISPLAY PANEL - 30mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution/ drops
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17030-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorYELLOW (Clear to Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17030-002-0130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other10/03/2018
    Labeler - Vetoquinol USA, Inc. (106824209)
    Registrant - Vetoquinol Products (106824209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amoli Organics Private Limited862234820API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropichem Research Labs, LLC dba Vetio603123068ANALYSIS, LABEL, MANUFACTURE, PACK
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