Label: INSTAMIX EMOLLIENT CONCENTRATE EC- glycerine concentrate

  • NDC Code(s): 55756-352-01, 55756-352-27
  • Packager: DeLaval Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 11, 2022

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  • INDICATIONS & USAGE

    An emollient concentrate designed for use with InstaMix™ Iodine Concentrate IC and Chlorine Dioxide CD X-10 Pre-Post Activator and Base using a DeLaval recommended on-site blending unit.

    Aids in reducing the spread of mastitis-causing organisms.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Emollient¤ ..................... 50.0%

    ¤from Glycerin

  • SPL UNCLASSIFIED SECTION

    Emollient

    PART B

    NPE

    FREE

    Formula

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    ! CAUTION

  • WARNINGS

    READ AND UNDERSTAND ALL INSTRUCTIONS BEFORE USING THIS PRODUCT

  • WARNINGS AND PRECAUTIONS

    Not For Human Use

    Additional Information on Safety Data Sheet

    CHEMTREC EMERGENCY NUMBER 1-800-424-9300

  • INDICATIONS & USAGE

    InstaMix™ Emollient Concentrate EC (Part B) is an emollient concentrate exclusively designed for use in combination with InstaMix™ Iodine Concentrate IC (Part A)and CD X-10 Pre-Post Activator and Base for on-site blending / production of teat dips.  To be blended with a DeLaval recommended on-site blending unit.

  • STORAGE AND HANDLING

    STORAGE AND DISPOSAL

    • THOROUGHLY RINSE ALL MEASURING DEVICES AND STORE OUT OF REACH OF CHILDREN.
    • Avoid contact with food or feed.  Avoid storing near heat or open flame.
    • Keep from freezing.
    • If product is frozen, thaw in warm room and mix well before using.
    • Keep container tightly closed when not in use.
    • Do not reuse empty container.
    • Rinse empty container before disposing in a safe manner.
  • INSTRUCTIONS FOR USE

    GENERAL INSTRUCTIONS

    • Do not use full strength.
    • Consult veterinarian before starting or continuing to use teat dip if cow's teats are sore or chapped.
    • Do not use teat dip for cleaning and/or sanitizing of dairy equipment.
    • Discard any teat sanitizing solution that becomes dirty or contaminated for any reason.
    • Good dairy practices suggest the thorough cleaning and sanitizing of teats before milking to avoid contamination and assist in the control of mastitis.
    • To be mixed with InstaMix​TM Iodine Concentrate IC (Part A) or CD X-10 Pre-Post Activator and Base using a DeLaval recommended on-site blending unit.

    DILUTIONS

    When blending the emollient concentrate with InstaMix™ Iodine Concentrate IC (Part A), choose one of the following combinations of iodine and emollient:

    % Iodine: 0.25, 0.5, 0.75, 1.0

    % emollient: 2.0, 3.5, 5.0, 10.0, 12.0, 14.0, 15.0, 20.0

    IMPORTANT!

    • 0.25% teat dip must be mixed on demand.
    • 0.5% - 10% teat dip must be used within two weeks after mixing.
    • Discard unused mixtures after above noted times.

    When blending the emollient concentrate to generate chlorine dioxide with CD X-10 Pre-Post Activator and Base, must stay within the following ranges:

    IMPORTANT! This is a two-part concentrate - must be mixed prior to use

    Target chlorine dioxide with sodium chlorite:  800 to 1200 ppm

    Target % emollient range: 0.5, 1.0, 3.0, 4.0, 5.0

    USE DIRECTIONS

    Pre-Dipping

    • Remove excess organic debris and forestrip.
    • Dip or spray cow's teats with properly diluted teat dip prepared with a DeLaval recommended on-site blending unit.
    • Allow a 30 second contact time.
    • Dry teats thoroughly with a clean, single-service paper towel.
    • Attach milker unit.

    Post-Dipping

    • Immediately after removing the milker unit, dip or spray each teat with properly diluted teat dip prepared with a DeLaval recommended on-site blending unit.
    • Before exposing cow's teats to below freezing temperatures, the teats should be thoroughly dry to reduce the potential of frostbite.  Failure to follow these instructions may result in frozen teats and injured animals.
  • SPL UNCLASSIFIED SECTION

    FIRST AID

    • Contact with product can cause irritation to eyes.  Avoid contact with eyes.
    • Eye Contact:  Flush with water.
    • If swalled:  Do not induce vomiting.  Call a physician or poison control center immediately.
  • SPL UNCLASSIFIED SECTION

    Manufactured for:  DeLaval, Inc.

    11100 N. Congress Avenue

    Kansas City, MO 64153

    Phone:  816-891-7700

    Manufactured by:  WestAgro, Inc.

    © 2022, Made in USA

    NET CONTENTS:

    LOT NO.:

    EXP. DATE:

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    INSTAMIX EMOLLIENT CONCENTRATE EC 
    glycerine concentrate
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55756-352
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN500 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    IODINE (UNII: 9679TC07X4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55756-352-01208.4 L in 1 DRUM
    2NDC:55756-352-271042.2 L in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/17/2019
    Labeler - DeLaval Inc. (173704867)
    Registrant - West Agro, Inc. (069288728)
    Establishment
    NameAddressID/FEIBusiness Operations
    West Agro, Inc.147528723manufacture, api manufacture, analysis, label, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    K Klean dba West Agro, Inc.002222368manufacture, api manufacture, analysis, label, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    West Agro, Inc.095906480manufacture, api manufacture, analysis, label, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    Alliance Dairy Service & Supplies Inc.117084685repack
    Establishment
    NameAddressID/FEIBusiness Operations
    West Agro, Inc.069288728api manufacture, manufacture, pack, label