PRIMA HP10- hydrogen peroxide solution

Prima HP10 by

Drug Labeling and Warnings

Prima HP10 by is a Animal medication manufactured, distributed, or labeled by DeLaval, WestAgro, Inc., K Klean dba WestArgo, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

PrimaTM HP10

Sanitizing post dip

Sanitizante post ordeno

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Hydrogen Peroxide......0.5%

with 10% Glycerin

Contains FD&C Yellow #6

SPL UNCLASSIFIED SECTION

H2O2

NPE FREE Formula

ACCELERATED HYDROGEN PEROXIDE

US Patent No.: 7,632,532

Other patents pending

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

! CAUTION

MANTINER FUERA DEL ALCANCE DE LOS NINOS

! CUIDADO

SPL UNCLASSIFIED SECTION

SI USTED 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.  Avoid contact with eyes.

If in Eyes: Flush with water. Remove contact lenses, if present, after first 5 minutes.  Then continue rinsing.  Get immediate medical attention.

If Swallowed:  Do not induce vomiting.  If victim is fully conscious, give a cupful of water.  Never give anything my mouth to an unconscious person.  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 container tightly closed when not in use.  If product has frozen, thaw in a warm room and shake well before using.  Do not reuse empty container.  Rinse empty container before disposing of in a safe manner.  Do not store in direct sunlight.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Not For Human Use

Additional Information on Safety Data Sheet

DOSAGE & ADMINISTRATION

GENERAL INSTRUCTIONS

• Use at full strength. (Do not dilute.)
• Consult your veterinarian before using teat dip on a cow with sore or chapped teats.
• Thoroughly clean and sanitize teat dip foaming cup before each milking.  Use fresh teat dip for each milking.
• Foaming solution should be changed if it becomes visibly dirty, or if sediment is introduced.
• Do not pour used dip back into original container.
• Do not use DeLaval PrimaTM HP10 for cleaning or sanitizing equipment.
• Good dairy practices suggest the thorough cleaning and sanitizing of teats before milking to avoid contamination and assist in the control of mastitis.

POST-DIPPING

• Immediately after removing milking unit, dip or spray teats with DeLaval PrimaTM HP10 teat dip.  Do not wipe.
• If outside temperature is below freezing, allow DeLaval PrimaTM HP10 teat dip to air-dry on teats before cow leaves the parlor; or allow teat dip to remain on teats for one minute, then dry teats with a single-service paper towel.  Failure to follow these directions may result in frozen teats and injured animals.

SPL UNCLASSIFIED SECTION

NET CONTENTS:        US GAL.

LOT NO.:

EXP. DATE:

Manufactured for:  DeLaval, Inc.

11100 N. Congress Avenue

Kansas City, MO 64153

Phone:  816-891-7700

Manufactured by:  WestAgro, Inc.,

© 2019, Made in USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRIMA HP10 
hydrogen peroxide solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 55756-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	5 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) (UNII: 7Q6P4JN1QT)
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)
LACTIC ACID (UNII: 33X04XA5AT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SALICYLIC ACID (UNII: O414PZ4LPZ)
GLYCERIN (UNII: PDC6A3C0OX)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
ETIDRONIC ACID (UNII: M2F465ROXU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55756-316-02	56.8 L in 1 DRUM
2	NDC: 55756-316-01	208.2 L in 1 DRUM
3	NDC: 55756-316-27	1041.0 L in 1 TANK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/28/2019

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 WestArgo, Inc.		002222368	analysis, api manufacture, label, manufacture, pack

Establishment
Name	Address	ID/FEI	Business Operations
WestAgro, Inc.		044610140	api manufacture, label, manufacture, pack