PREP 8X8- lactic acid solution solution

PREP 8X8 by

Drug Labeling and Warnings

PREP 8X8 by is a Animal medication manufactured, distributed, or labeled by AgroChem USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PREP 8X8

TEAT DIP CONCENTRATE

WARNINGS

WARNING

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

WARNINGS AND PRECAUTIONS

NOT FOR HUMAN USE.

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

NDC: 17307-3017-3

NET CONTENTS:  55 GALLON (208.2L)

LOT:

EXP. DATE:

ACTIVE INGREDIENT

ACTIVE  INGREDIENT (when diluted 1:7):  Lactic  Acid  2%

INACTIVE INGREDIENT

EMOLLIENTS  (when  diluted  1:7):  8%

SPL UNCLASSIFIED SECTION

Use  PREP  8X8  CONCENTRATE  effectively to  reduce  the  spread  of  mastitis  causing  organisms.  Recommended  for  pre  milking  applications.

INSTRUCTIONS FOR USE

DIRECTIONS:

IMPORTANT:  THIS  IS  A  CONCENTRATE  AND  MUST  BE  DILUTED  WITH  WATER  PRIOR  TO  USE.  Mix  (1)  part  concentrate  to  (7)  parts  of  clean, soft  water.  Mix  by  volume

General Use

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.

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 8X8 
lactic acid solution solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17307-3017
Route of Administration	topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	0.184 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)
Glycerin (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17307-3017-1	19 kg in 1 CONTAINER
2	NDC: 17307-3017-2	57 kg in 1 DRUM
3	NDC: 17307-3017-3	208 kg in 1 DRUM
4	NDC: 17307-3017-4	1003 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/06/2024

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