Label: 4XLA ACTIVATOR- lactic acid liquid

  • NDC Code(s): 29983-1032-4, 29983-1032-6, 29983-1032-8, 29983-1032-9
  • Packager: IBA
  • 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 June 29, 2015

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

  • GERMICIDAL PRE-MILKING TREATMENTAn aid in reducing the spread of organisms which may cause mastitis.FOR USE ONLY WITH 4XLA BASE

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    CAUTION: For external use only. Not for use in sanitizing dairy equipment. Do not mix with any other teat dip or other product. Avoid contact with food. Store at room temperature. Protect from heat and freezing. Always store away from continuous artificial light or direct sunlight. Avoid contact with eyes. If contact occurs, flush eyes with large quantities of water. See a physician if irritation develops.

    ACTIVE INGREDIENT: 2.5% Lactic Acid


    CONTAINS: Glycerin

    DISPOSAL: Unused teat dip may be diluted with water and flushed down the drain. Do not reuse containers. Empty containers should be thoroughly rinsed and taken to a recycling center

    DIRECTIONS FOR USE: Measure equal volumes of 4XLA base and 4XLA activator into a clean dip cup/container and mix until the color is uniform throughout. Do not dilute. Mix only enough product for one milking of the herd. Dip cups should be washed after each milking.
    APPLICATION:
    Pre-Milking: If teats are visibly dirty, wash and dry teats with a single service towel prior to dipping. Before each cow is milked, dip the teats as far up as possible. Leave 4XLA teat dip on teats for at least 15-30 seconds. Wipe teats dry using a single service towel before milking.
    Post-Milking: Immediately after milking, dip teats at least 2/3 to all their length in 4XLA Teat Dip. Allow to air dry. DO NOT WIPE OFF. 4XLA Teat Dip can be used as a post dip alone, or as a pre- and post-milking teat dip.
    Always use freshly mixed, full strength 4XLA Teat Dip. If product in dip cup becomes visibly dirty , discard contents and fill with fresh 4XLA Teat Dip. 4XLA Teat Dip maybe diluted with water and safely flushed down the drain.

    Note1: If teat irritation occurs, discontinue use until irritation subsides. Consult your veterinarian and milking equipment service personnel if irritation persists.
    Note 2:AVOIDFREEZING. However, freezing will not affect this product provided that the contents are thawed completely and agitated thoroughly before mixing base and activator together.
    Note 3: The gold color in the mixed product fades with time. At higher temperatures he fading is more rapid. However this will not affect the efficacy of the product.
    Note 4: 4XLA should be used only with a compatible pre-dip or udder wash.


    AVOID FREEZING: If product is exposed to freezing temperatures, components must be mixed thoroughly prior to use

    KEEP OUT OF REACH OF CHILDREN
    NOT FOR HUMAN USE
    ALWAYS SEEK IMMEDIATE MEDICAL ATTENTION
    FOR MEDICAL EMERGENCIES CALL 1-800-424-9300

    READ THIS NOTICE
    Ecolab Inc. and IBA's liability on any claim, whether in negligence or in any tort or in contract or otherwise, with respect to products delivered hereunder, shall not exceed the purchase price of the products sold or, if Ecolab Inc. and IBA shall so elect, buyer shall be entitled only to a replacement of the product. In no event shall Ecolab Inc. and IBA be liable for buyers’ incidental or consequential damages.

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  • INGREDIENTS AND APPEARANCE
    4XLA ACTIVATOR 
    lactic acid liquid
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:29983-1032
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID 2.5 kg  in 100 kg
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29983-1032-4 19.39 kg in 1 PAIL
    2 NDC:29983-1032-6 58.17 kg in 1 DRUM
    3 NDC:29983-1032-8 213.30 kg in 1 DRUM
    4 NDC:29983-1032-9 1066.503 kg in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/29/2015
    Labeler - IBA (019494160)
    Establishment
    Name Address ID/FEI Business Operations
    Morgan Gallacher Inc. DBA in Custom Chemical Formulators Inc. 028311595 manufacture, api manufacture, pack
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