XTRA 7 PART A- lactic acid solution

XTRA 7 PART A by

Drug Labeling and Warnings

XTRA 7 PART A by is a Animal medication manufactured, distributed, or labeled by AgroChem USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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XTRA 7 PART A

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.

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

NDC: 17307-3651-3

NET  CONTENTS:  55  GALLON  (208.2L)

LOT:

EXP. DATE:

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Lactic Acid 2.64%

INACTIVE INGREDIENT

EMOLLIENTS: 14%

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XTRA-7 is  a  two-part  Chlorine  Dioxide  teat  dip  that  can  be  effectively  used  to  reduce  the  spread  of  mastitis  causing  organisms.  Recommended  for  pre  and  post  milking  applications.

INSTRUCTIONS FOR USE

DIRECTIONS:

IMPORTANT:   MUST BE  MIXED  PRIOR  TO  USE.  Mix PART A  &  PART B  in  equal  parts.   Mix by volume.  CREATES CHLORINE DIOXIDE.   Reaches minimum  Chlorine  Dioxide  levels  within  15  minutes  of  mixing.  Will maintain minimum  Chlorine  Dioxide  levels  for  up  to  24  hours.  It is  recommended  to  replace  with  freshly  mixed  solution  after  24 hours.

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.

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Manufactured By:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRA 7 PART A 
lactic acid solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17307-3007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	0.03 kg  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17307-3007-1	19 kg in 1 CONTAINER
2	NDC: 17307-3007-2	57 kg in 1 DRUM
3	NDC: 17307-3007-3	208 kg in 1 DRUM
4	NDC: 17307-3007-4	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