Label: CLOTRIMAZOLE solution/ drops

  • 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 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