Label: LELY QUARESS PREMO 55- iodine solution

  • NDC Code(s): 86190-008-17, 86190-008-21
  • Packager: Lely North America, Inc.
  • Category: OTC ANIMAL DRUG LABEL

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 October 2, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SAFE HANDLING WARNING

    KEEP OUT OF REACH OF CHILDREN

    NOT FOR HUMAN USE

    Attention

    For External Use Only

    Wash hands thoroughly after handling.

    Get medical advice/ attention if you feel unwell.

  • VETERINARY INDICATIONS

    DIRECTIONS

    Lely Quaress Premo 55 is intended to be used with Lely robotic milking systems.

    IMPORTANT: Do not mix with water, any other teat dips, or other products unless specified in product use instructions. If transferred from this container to any other, make sure that the other container is thoroughly pre-cleaned and bears the proper container labeling.

    Robotics Milking Pre-Milking/Prepping Directions

    Pre-milking/prepping: When used with the Lely robotic milking system teats should be prepped according to the recommendations of Lely, using the appropriate Astri brush wash product and procedure.

    Pre-Milk Dipping Directions

    Pre-milk/prepping: Wash teats thoroughly just prior to next milking with appropriate udder wash solution or pre-milking teat dip or teat spray to avoid contamination of milk. Teats should then be dried with single-service towels. Use proper procedures for udder washing or pre-dipping.

    Pre-Milk Spraying or Dipping Directions

    Pre-milk spraying or dipping: Before each cow is milked, spray or dip entire teat with Lely Quaress Premo 55. Wipe teats after spraying using single-service towels to avoid contamination of milk.

    Post-Milk Spraying or Dipping Directions

    Post-milk spraying or dipping: Using fresh Lely Quaress Premo 55, spray or dip the

    full-length of each teat. Do not wipe. Allow to air dry. Do not turn cows out in freezing weather until the product is completely dry.

    Expanded Usage: When freshening cows, begin spraying or dipping teats twice daily for about 10 days before calving.

    PRECAUTION: Lely Quaress Premo 55 is not intended to cure or help the healing of chapped or irritated teats. As with any germicide, irritation or sensitization may occur in sensitive animals. In case of teat irritation or chapping, have the condition examined and, if necessary, treated by a veterinarian.

  • OTHER SAFETY INFORMATION

    READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT

    EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

  • Principal display panel and representative label

    Lely

    Lely Quaress

    Premo 55

    Sanitizing teat spray

    56.8 l / 15 US gal

    Lely Astronaut

    TOTAL INGREDIENTS   100.0%ACTIVE INGREDIENTS   0.5%INERT INGREDIENTS   99.5%
    Active Ingredients   0.5%Iodine   0.5%(contains glycerin, propylene glycol)
    Inert Ingredients   99.5%

    An aid in reducing the spread of organisms which may cause mastitis.

    Distributed by:

    Lely North America · 1948 Lely Park Way · Pella, Iowa 50219 USA · tel: 1 888 245 4684

    Manufactured by:

    Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 392 3392

    © 2023 Ecolab USA Inc. · All rights reserved

    Made in United States

    www.ecolab.com

    representative label panel 1

    representative label panel 2

  • INGREDIENTS AND APPEARANCE
    LELY QUARESS PREMO 55 
    iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86190-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86190-008-1756800 mL in 1 DRUM
    2NDC:86190-008-21208000 mL in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/02/2023
    Labeler - Lely North America, Inc. (798881780)