Label: OCEANBLU BARRIER- glycolic acid solution

  • NDC Code(s): 55756-065-01, 55756-065-02, 55756-065-08, 55756-065-27
  • Packager: DeLaval
  • 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 September 25, 2024

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  • PURPOSE

    READY-TO-USE DISINFECTING TEAT DIP

    Aids in reducing the spread of mastitis-causing organisms

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Glycolic Acid ................ 3.0%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    Emollient* ............... 10.0%

    * From Glycerin and Sorbitol

  • SPL UNCLASSIFIED SECTION

    GlyTecTM

    US Patent:  US10028924

  • SPL UNCLASSIFIED SECTION

    2065-G0724

    GLY

    Barrier Technology

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    !CAUTION

    MANTENER FUERA DEL ALCANCE DE LOST NINOS

    !CUIDADO

  • SPL UNCLASSIFIED SECTION

    2065

    NDC NUMBER 55756-065

  • SPL UNCLASSIFIED SECTION

    SI USTED NO PUEDE LEER ESTA ETIQUETA, POR FAVOR PIDA A ALGUIEN MAS QUE SE LA LEA ANTES DE USAR ESTE PRODUCTO

    READ AND UNDERSTAND ALL INSTRUCTIONS BEFORE USING THIS PRODUCT

  • SPL UNCLASSIFIED SECTION

    FIRST AID

    Contact with product can cause irritation to eyes.  Avoid contact with eyes.

    If In Eyes:  Flush with water.  Remove contact lenses, if present, after first 5 minutes.  Then continue rinsing.

    If Swallowed:  Do not induce vomiting.  Get immediate medical attention.

  • STORAGE AND HANDLING

    STORAGE AND DISPOSAL

    THOROUGHLY RINSE ALL MEASURING DEVICES AND STORE OUT OF REACH OF CHILDREN.  Avoid contact with food or feed.  Avoid storing near heat or open flame.  Keep from freezing.  If product is frozen, thaw in warm room and mix well before using.  Keep from exposing product to direct sunlight.  Keep container tightly closed when not in use.  Do not reuse empty container.  Rinse container before disposing in a safe manner.  Keep away from chlorine and chlorinated products.

  • SPL UNCLASSIFIED SECTION

    CHEM-TREC EMERGENCY NUMBER 1-800-424-9300

  • SPL UNCLASSIFIED SECTION

    Not For Human Use

    Additional Information on Safety Data Sheet

  • INSTRUCTIONS FOR USE

    GENERAL INSTRUCTIONS

    • OceanBlu® Barrier is a highly visible, persistent barrier post-dip with extended disinfection while hydrating and softening teats.
    • Use OceanBlu® Barrier at full strength.  Do not dilute.
    • Consult your veterinarian before using a teat dip on a cow with sore or chapped teats.
    • Thoroughly clean and sanitize teat dip cup before milking.
    • Use fresh teat dip for each milking.  Dip solution should be changed if it becomes visibly dirty, or if sediment is introduced.  Do not pour used teat dip back into original container.
    • Do not use for cleaning or sanitizing equipment.
    • Discard any teat dip that becomes contaiminated for any reason.

    PRE-DIPPING

    • For optimal removal of organic debris and to remove any residual OceanBlu® Barrier film, use a DeLaval approved pre-dip following label instructions.

    POST-DIPPING

    • Immediately after removing inflations, dip cow's teats with OceanBlu® Barrier.
    • Do not wipe.​
    • If outside temperature is below freezing, allow dip to air-dry on cow's teats before cow is released outside.  Failure to follow these directions may result in frozen teats and injured animals.
  • SPL UNCLASSIFIED SECTION

    Manufactured for: DeLaval, Inc.
    11100 N. Congress Avenue
    Kansas City, MO 64153
    Phone: 816-891-7700
    Manufactured by: WestAgro, Inc.,
    ©2024, Made in USA

  • SPL UNCLASSIFIED SECTION

    NET CONTENTS:

    LOT NO.:

    EXP. DATE:

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    OCEANBLU BARRIER 
    glycolic acid solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55756-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID30.4 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SORBITOL (UNII: 506T60A25R)  
    C9-11 PARETH-8 (UNII: 80E6PSE1XL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    1-OCTANESULFONIC ACID (UNII: DU4821I15A)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55756-065-0256.7 L in 1 DRUM
    2NDC:55756-065-01208.4 L in 1 DRUM
    3NDC:55756-065-0818.9 L in 1 PAIL
    4NDC:55756-065-271041 L in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2014
    Labeler - DeLaval (173704867)
    Registrant - WestAgro, Inc. (069288728)
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.147528723analysis, api manufacture, label, manufacture, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.095906480analysis, api manufacture, label, manufacture, pack
    Establishment
    NameAddressID/FEIBusiness Operations
    Graham Dairy Supply Inc014157770repack
    Establishment
    NameAddressID/FEIBusiness Operations
    JBZ Dairy Advantage Inc016914287repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Ederer Dairy Supply LLC022794466repack
    Establishment
    NameAddressID/FEIBusiness Operations
    WestAgro, Inc.069288728api manufacture, manufacture, pack, label
    Establishment
    NameAddressID/FEIBusiness Operations
    Genex Cooperative, Inc003437378repack