Label: NICH PVPI UREA- povidone-iodine for solution

  • 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 May 27, 2013

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  • INDICATIONS & USAGE

    USES: To prepare a solution of iodine for flushing wounds, or for topical disinfection.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Dissolve one bolus in 50 to 100 ml of water. Apply as a soak or cleanse area with solution on gauze.

    This solutions is for cleaning wounds in small animals, Equine and Bovine species.

  • WARNINGS

    WARNING:

    For deep or puncture wounds or serious burns, consult a veterinarian.
    Avoid contact with eyes or mucous membranes.
    If contact occurs with eyes flush with water for 15 minutes. If irritation occurs seek medical attention.

  • ACTIVE INGREDIENT

    Each bolus contains: 250 mg. available iodine as polyvinylpyrrolidone iodine complex in a buffered urea base.

  • WHEN USING

    FOR TOPICAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • SPL UNCLASSIFIED SECTION

    TAKE TIME - OBSERVE LABEL DIRECTIONS


    Distributed By

    Nich Marketers, Inc.

    Gulf Breeze, FL 32563

  • PRINCIPAL DISPLAY PANEL

    NDC NUMBER 42065-444-01

    NICH

    PVPI UREA

    BOLUS

    PH BALANCED

    NOT FOR HUMAN USE

    FOR VETERINARY USE ONLY

    NET CONTENTS: 50 BOLUSES

    NICH

  • INGREDIENTS AND APPEARANCE
    NICH PVPI UREA  
    povidone-iodine for solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:42065-444
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42065-444-0150 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/08/2011
    Labeler - Nich Marketers, Inc (883363012)
    Establishment
    NameAddressID/FEIBusiness Operations
    Performance Products, Inc006265888manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Marcus Research Laboratory, Inc.075910356api manufacture