Label: 4XLA- lactic acid solution

  • NDC Code(s): 47593-424-16, 47593-424-17, 47593-424-21, 47593-424-44
  • Packager: Ecolab Inc.
  • 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 June 15, 2018

If you are a consumer or patient please visit this version.

  • SAFE HANDLING WARNING

    NOT FOR HUMAN USE

    FOR USE ONLY WITH 4XLA® BASE

    ATTENTION: For External Use Only. Wash handsthoroughly after handling. Get medical advice/attention if you feel unwell.

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  • VETERINARY INDICATIONS

    DIRECTIONS FOR USE: Measure equal

    volumes of 4XLA® base and 4XLA

    activator into a clean dip cup/containe r

    and mix until the color is uniform

    through-out. 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. 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.

    Note 1: If teat irritation occurs, discontinue

    use until irritation subsides. Consult your

    veterinarian and milking equipment service

    personnel if irritation persists.

    Note 2: The gold color in the mixed product

    fades with time. At higher temperatures

    the fading is more rapid. However, this

    will not affect the efficacy of the product.

    Note 3:4XLA should be used only with a

    compatible pre-dip or udder wash.

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  • OTHER SAFETY INFORMATION

    Not for use in sanitizing dairy equipment. Do notmix with any other teat dip or other product. Avoidcontact with food. Store at room temperature.Protect from heat and freezing. Always store awayfrom continuous artificial light or direct sunlight.

    DISPOSAL: Unused teat dip may be diluted withwater and flushed down drain. Do not reusecontainers. Empty containers should be thoroughlyrinsed with water and taken to a recycling center.

    KEEP OUT OF THE REACH OF CHILDREN

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

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  • PRINCIPAL DISPLAY PANEL

    SELECT SIRES INC. 6301911

    4XLA®GERMICIDAL PRE- & POST-MILKING TEAT DIP

    An aid in reducing the spread of organisms which may causemastitis

    Contains an emollient system

    ACTIVATOR

    ACTIVE INGREDIENT:

    Lactic Acid ...........................................................2.5%

    INERT INGREDIENTS:.................................... 87.5%

    SKIN CONDITIONING SYSTEM:

    (contains glycerin) .......................................... 10.0%

    TOTAL:.............................................................100.0%

    Distributed by:

    Select Sires, Inc.

    11740 U.S. 42N P.O. Box 143

    Plain City, OH 43064-0143

    614-873-4683

    www.selectsires.com

    4XLA® is a registered trademark of

    Ecolab Inc., St. Paul, MN 55102

    Made in USA

    Patent USRE37263

    U.S. Patent 5,384,134

    Foreign Patents Issued and Pending

    18.9 L (5 US GAL)

    representative label

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  • INGREDIENTS AND APPEARANCE
    4XLA 
    lactic acid solution
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:47593-424
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID 25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47593-424-16 18900 mL in 1 PAIL
    2 NDC:47593-424-17 56800 mL in 1 DRUM
    3 NDC:47593-424-21 208200 mL in 1 DRUM
    4 NDC:47593-424-44 1134000 mL in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/08/2014
    Labeler - Ecolab Inc. (006154611)
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