Label: XTRA-7 (PART B)- sodium chlorite solution

  • NDC Code(s): 17307-3651-1, 17307-3651-2, 17307-3651-3, 17307-3651-4
  • Packager: AgroChem USA, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 1, 2023

If you are a consumer or patient please visit this version.

  • 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

    image description
  • INGREDIENTS AND APPEARANCE
    XTRA-7 (PART B) 
    sodium chlorite solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17307-3651
    Route of Administrationtopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6) SODIUM CHLORITE0.02106 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.97894 kg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17307-3651-119 kg in 1 CONTAINER
    2NDC:17307-3651-257 kg in 1 DRUM
    3NDC:17307-3651-3208 kg in 1 DRUM
    4NDC:17307-3651-41040 kg in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/12/2023
    Labeler - AgroChem USA, LLC (118336116)
    Registrant - AgroChem USA, LLC (118336116)
    Establishment
    NameAddressID/FEIBusiness Operations
    AgroChem USA, LLC118336116api manufacture, manufacture, analysis, label, pack