PREP 8X RTU- lactic acid solution

Prep 8X RTU by

Drug Labeling and Warnings

Prep 8X RTU by is a Animal medication manufactured, distributed, or labeled by AgroChem USA, LLC, JBZ Dairy Advantage Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Prep 8X RTU

WARNINGS

WARNING

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

WARNINGS AND PRECAUTIONS

AVOID FREEZING.

KEEP OUT OF DIRECT SUNLIGHT.

CAUSES SERIOUS EYE IRRITATION.

FOR FARM AND INDUSTRIAL USE ONLY.

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 AND HANDLING

STORAGE:  Store locked up.                       

DISPOSAL: Dispose of contents/ container to an approved waste disposal plant.

SPL UNCLASSIFIED SECTION

EMERGENCY TELEPHONE NUMBER (Chemtrec) 800-424-9300 CCN205494

NET CONTENTS: 55 Gallons

LOT:

EXP. DATE:

ACTIVE INGREDIENT

ACTIVE INGREDIENT:  Lactic Acid  2%

INACTIVE INGREDIENT

EMOLLIENTS:  4%

SPL UNCLASSIFIED SECTION

Use PREP 8X RTU  effectively to  reduce  the  spread  of  mastitis  causing  organisms.  Recommended  for  pre  milking  applications

INSTRUCTIONS FOR USE

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.

This product 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 to  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.

Use PREP  8X RTU effectively to  reduce  the  spread  of  mastitis  causing  organisms.  Recommended for  pre  milking  applications.

SPL UNCLASSIFIED SECTION

Manufactured By:

AgroChem USA, LLC 26 Freedom Way Saratoga Springs, NY 12866   (518)226-4850

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREP 8X RTU 
lactic acid solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17307-3008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	0.023 kg  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17307-3008-1	19 kg in 1 CONTAINER
2	NDC: 17307-3008-2	57 kg in 1 DRUM
3	NDC: 17307-3008-3	208 kg in 1 DRUM
4	NDC: 17307-3008-4	1041 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/13/2023

Labeler - AgroChem USA, LLC (118336116)

Registrant - AgroChem USA, LLC (118336116)

Establishment
Name	Address	ID/FEI	Business Operations
AgroChem USA, LLC		118336116	api manufacture, manufacture, analysis, label, pack