Label: AURA BARRIER- glyceryl laurate and lactic acid solution

  • NDC Code(s): 17307-3934-1, 17307-3934-2, 17307-3934-3, 17307-3934-4
  • Packager: AgroChem 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 February 9, 2018

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  • DESCRIPTION

    AURA BARRIER DIP

    TEAT DIP

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  • WARNINGS

    WARNING

    CAUSES SERIOUS EYE IRRITATION.

    FOR FARM AND INDUSTRIAL USE ONLY.

    KEEP OUT OF REACH OF CHILDREN.

    KEEP OUT OF DIRECT SUNLIGHT.

    AVOID FREEZING.

    PREVENTION:  Wash skin thoroughly after handling. Wear eye protection/ face protection.

    FIRST AID / RESPONSE: 

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists:  Get medical advice/ attention.            

    STORAGE:  Store locked up.                                                       

    DISPOSAL: Dispose of contents/ container to an approved waste disposal plant              

    EMERGENCY TELEPHONE NUMBER (Chemtrec) 800-424-9300 CCN205494

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  • ACTIVE INGREDIENT

    INGREDIENTS:

    Active Ingredients:

        Glycerol Monolaurate - 1%

         Lactic Acid - 3%

         Emollients - 7.5%

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  • INSTRUCTIONS FOR USE

    Use Aura Barrier Dip effectively to reduce the spread of mastitis causing organisms.   The specially selected emollients in Aura Barrier Dip soften teat skin and protect the surface of the teat by keeping it moistened and smooth. Aura Barrier Dip is suitable for use as a pre or post dip. 

    Directions:

    General Use

    Ready to use.  Do not dilute.  Do not mix product with water, any other teat dips, or other product.

    Use a teat dip cup to apply.  Clean dip cup just prior to use.

    If cow’s teats are sore or chapped, consult a veterinarian before starting or continuing to use teat dip.

    If transferred from this container to any other, make sure that the other container is thoroughly pre-cleaned and bears the proper container labeling for this product. 

    If product in dip cup becomes visibly dirty, discard contents and replenish with undiluted product. Do not reuse or return any unused product to the original container.

    Teat Sprays can also be foamed or sprayed using recommended equipment.

    Pre Dipping Use

    Perform forestripping and inspect teats for clinical mastitis.

    Pre-wash teats thoroughly just prior milking with appropriate udder wash solution or pre-milking teat dip. Teats should then be dried with single-service towels

    Just before each cow is milked, dip, foam, or spray, each teat full-length into the teat dip or foam cup containing product.

    Allow product to stand for 30 seconds.

    Wipe teats dry after dipping, using single-service towels to avoid contamination of milk.

    Post Dipping Use

    Immediately after each milking, use product.

    Dip each teat full-length into the teat dip cup containing product.  Allow to air dry.  Do not wipe.

    If outside temperature is below freezing, allow to air dry on the teat before cow leaves the parlor.

    Extended Use  

    When a cow is being dried off, the teats should be dipped in product, once a day for 3-4 days after the last milking.

    Dipping should be resumed at least twice daily one week before calving.

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  • INGREDIENTS AND APPEARANCE
    AURA BARRIER 
    glyceryl laurate and lactic acid solution
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17307-3934
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERYL LAURATE (UNII: Y98611C087) (GLYCERYL LAURATE - UNII:Y98611C087) GLYCERYL LAURATE 0.0025 kg  in 1 kg
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID 0.03 kg  in 1 kg
    Inactive Ingredients
    Ingredient Name Strength
    LANOLIN (UNII: 7EV65EAW6H) 0.0025 kg  in 1 kg
    GLYCERIN (UNII: PDC6A3C0OX) 0.04 kg  in 1 kg
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.03 kg  in 1 kg
    C10-16 PARETH-1 (UNII: 3Y76363WPB) 0.003 kg  in 1 kg
    C9-11 PARETH-3 (UNII: 8O4974OMUO) 0.003 kg  in 1 kg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.035 kg  in 1 kg
    XANTHAN GUM (UNII: TTV12P4NEE) 0.0033 kg  in 1 kg
    ALGINIC ACID (UNII: 8C3Z4148WZ) 0.0022 kg  in 1 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17307-3934-1 19 kg in 1 CONTAINER
    2 NDC:17307-3934-2 57 kg in 1 DRUM
    3 NDC:17307-3934-3 208 kg in 1 DRUM
    4 NDC:17307-3934-4 1040 kg in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/01/2013
    Labeler - AgroChem Inc (805427700)
    Establishment
    Name Address ID/FEI Business Operations
    AgroChem Inc. 805427700 api manufacture, manufacture
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