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
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
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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.
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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.
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OCEANBLU BARRIER
glycolic acid solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55756-065 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID 30.4 g in 1 L Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:55756-065-02 56.7 L in 1 DRUM 2 NDC:55756-065-01 208.4 L in 1 DRUM 3 NDC:55756-065-08 18.9 L in 1 PAIL 4 NDC:55756-065-27 1041 L in 1 TANK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/01/2014 Labeler - DeLaval (173704867) Registrant - WestAgro, Inc. (069288728) Establishment Name Address ID/FEI Business Operations WestAgro, Inc. 147528723 analysis, api manufacture, label, manufacture, pack Establishment Name Address ID/FEI Business Operations WestAgro, Inc. 095906480 analysis, api manufacture, label, manufacture, pack Establishment Name Address ID/FEI Business Operations Graham Dairy Supply Inc 014157770 repack Establishment Name Address ID/FEI Business Operations JBZ Dairy Advantage Inc 016914287 repack Establishment Name Address ID/FEI Business Operations Ederer Dairy Supply LLC 022794466 repack Establishment Name Address ID/FEI Business Operations WestAgro, Inc. 069288728 api manufacture, manufacture, pack, label Establishment Name Address ID/FEI Business Operations Genex Cooperative, Inc 003437378 repack