XTRA-7 (PART B)- sodium chlorite solution

Xtra-7 (Part B) by

Drug Labeling and Warnings

Xtra-7 (Part B) by is a Animal medication manufactured, distributed, or labeled by AgroChem USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

XTRA-7 (Part B)

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: 17307-3651-3

NET  CONTENTS:  55  GALLON  (208.2L)

LOT:

EXP. DATE:

ACTIVE INGREDIENT

ACTIVE INGREDIENT:  Sodium Chlorite     -      0.65 %

SPL UNCLASSIFIED SECTION

XTRA-7 is a two-part  Chlorine Dioxide  teat  dip  and  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 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRA-7 (PART B) 
sodium chlorite solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17307-3651
Route of Administration	topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6)	SODIUM CHLORITE	0.02106 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	0.97894 kg  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17307-3651-1	19 kg in 1 CONTAINER
2	NDC: 17307-3651-2	57 kg in 1 DRUM
3	NDC: 17307-3651-3	208 kg in 1 DRUM
4	NDC: 17307-3651-4	1040 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/12/2023

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