Label: INSTAMIX GLYCOLIC CONCENTRATE- glycerin, glycolic acid concentrate

  • 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 January 5, 2022

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  • PURPOSE

    A glycolic concentrate designed for use with InstaMixTM G Emollient Concentrate using a DeLaval recommended on-site blending unit.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Glycolic Acid ................... 15% 

    Emollient* ...................... 10%

    *from Glycerin

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    ! CAUTION

  • SPL UNCLASSIFIED SECTION

    READ AND UNDERSTAND ALL INSTRUCTIONS BEFORE USING THIS PRODUCT

  • SPL UNCLASSIFIED SECTION

    InstaMixTM Glycolic Concentrate (Part A) is a glycolic concentrate exclusively designed for use in combination with InstaMixTM G Emollient Concentrate (Part B) for on-site blending/production of teat dips.  To be blended with a DeLaval recommended on-site blending unit.

  • SPL UNCLASSIFIED SECTION

    FIRST AID

    Immediately call a poison control center or doctor/physician

    Eye contact: Rinse cautiously with water for several minutes.  Remove contact lenses, if present and easy to do.  Continue rinsing.  Immediately call a poison control center or doctor/physician.

    If on Skin:  Remove/Take off immediately all contaminated clothing.  Rinse skin with water/shower.  Wash contaminated clothing before reuse.

    If Inhaled:  Remove victim to fresh air and keep at rest in a position comfortable for breathing.  Immediately call a poison control center or doctor/physician.

    If swallowed:  Rinse mouth.  Do not induce vomiting.

  • 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. Store in a cool, dry space.  Keep container tightly closed when not in use.  Do not reuse empty container.  Dispose of contents/container to an approved waste disposal plant.

  • SPL UNCLASSIFIED SECTION

    CHEMTREC EMERGENCY NUMBER 1-800-424-9300

  • WARNINGS AND PRECAUTIONS

    Not For Human Use

    Additional Information on Safety Data Sheet

  • INDICATIONS & USAGE

    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 equpment.
    • 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 InstaMixTM G Emollient Concentrate (Part B) using a DeLaval recommended on-site blending unit.  Can be diluted to create 6 formula options

    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.
     Setting on InstaMixTM
                                     InstamixTM Formula                    % Glycolic Acid                      % Emollient
                                     Glycolic 3%-2%                             3                              2
                                     Glycolic 3%-5%                              3                               5 

                                     Glycolic 3%-10%

                                 3                              10 
                                     Glycolic 3%-20%                              3                              20 
                                     Glycolic 3%-30%                             3                              30 
                                     Glycolic 3%-40%                              3                              40 

  • SPL UNCLASSIFIED SECTION

    NET CONTENTS:            US GAL

    LOT NO.:

    EXP. DATE:

    Manufactured for:  DeLaval, Inc.

    11100 N. Congress Avenue

    Kansas City, MO 64153

    Phone:  816-891-7700

    Manufactured by:  WestAgro, Inc.,

    © 2021, Made in USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    INSTAMIX GLYCOLIC CONCENTRATE 
    glycerin, glycolic acid concentrate
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55756-157
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID150 g  in 1 L
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN100 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM CAPRYLYL SULFONATE (UNII: J46EZ5JYB3)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    C9-11 PARETH-8 (UNII: 80E6PSE1XL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55756-157-01208 L in 1 DRUM
    2NDC:55756-157-271041 L in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/06/2021
    Labeler - DeLaval (173704867)
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.147528723analysis, api manufacture, manufacture, pack, label
    Establishment
    NameAddressID/FEIBusiness Operations
    K Klean dba WestAgro, Inc.002222368analysis, api manufacture, manufacture, pack, label
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.095906480analysis, api manufacture, manufacture, pack, label
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.069288728api manufacture, manufacture, pack, label