OCEANBLU BARRIER- glycolic acid solution

OceanBlu Barrier by

Drug Labeling and Warnings

OceanBlu Barrier by is a Animal medication manufactured, distributed, or labeled by DeLaval, WestAgro, Inc., K Klean dba WestAgro, Inc., Graham Dairy Supply Inc, JBZ Dairy Advantage Inc, Ederer Dairy Supply LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Sanitizing Post dip Barrier with 10% emollients

Aids in reducing the spread of mastitis-causing organisms

Desinfectante post ordeno con 10% de glicerina

Ayuda a reducir la transmision de microorganismos que causan mastitis

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-C0116

GLY

NPE FREE Formula

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 USNG 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 HANDLING

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

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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.
• 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.
©2018, Made in USA

SPL UNCLASSIFIED SECTION

NET CONTENTS:

LOT NO.:

EXP. DATE:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OCEANBLU BARRIER 
glycolic acid solution

Product 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
K Klean dba WestAgro, Inc.		002222368	analysis, api manufacture, label, manufacture, pack

Establishment
Name	Address	ID/FEI	Business Operations
WestAgro, Inc.		044610140	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		076158336	repack