Label: ULTRA-SOFT BARRIER- bronopol solution solution

  • NDC Code(s): 17307-3530-1, 17307-3530-2, 17307-3530-3, 17307-3530-4
  • 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 March 11, 2020

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  • ULTRA-SOFT BARRIER

    ULTRA-SOFT BARRIER

    BRONOPOL TEAT DIP

  • WARNINGS AND PRECAUTIONS

    WARNING

    CAUSES SERIOUS EYE IRRITATION

    FOR FARM AND INDUSTRIAL USE ONLY.

    KEEP OUT OF REACH OF CHILDREN.

    KEEP OUT OF DIRECT SUNLIGHT.

    AVOID FREEZING  - PRODUCT WILL BECOME THICKER WITH COLD.

    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

  • ACTIVE INGREDIENT

    INGREDIENTS:

    Active Ingredients:

      Bonopol – 0.25% 

      Emollients – 14% (Lanolin & Glycerine)

  • INSTRUCTIONS FOR USE

    Use Ultra-Soft  Barrier Dip effectively to reduce the spread of mastitis causing organisms.   The specially selected emollients in Ultra-Soft Barrier Dip soften teat skin and protect the surface of the teat by keeping it moistened and smooth. Ultra-Soft 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.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ULTRA-SOFT BARRIER 
    bronopol solution solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17307-3530
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRONOPOL (UNII: 6PU1E16C9W) (BRONOPOL - UNII:6PU1E16C9W) BRONOPOL0.0025 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    C10-16 PARETH-1 (UNII: 3Y76363WPB) .00445 kg  in 1 kg
    C9-11 PARETH-3 (UNII: 8O4974OMUO) .00445 kg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17307-3530-119 kg in 1 CONTAINER
    2NDC:17307-3530-257 kg in 1 DRUM
    3NDC:17307-3530-3208 kg in 1 DRUM
    4NDC:17307-3530-41040 kg in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/11/2020
    Labeler - AgroChem Inc (805427700)
    Registrant - AgroChem Inc (805427700)
    Establishment
    NameAddressID/FEIBusiness Operations
    AgroChem Inc805427700api manufacture, manufacture