Label: AURA CONCENTRATE- lactic acid teat dip solution

  • NDC Code(s): 17307-3022-1, 17307-3022-2, 17307-3022-3, 17307-3022-4
  • 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 July 17, 2024

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

  • SPL UNCLASSIFIED SECTION

    AURA CONCENTRATE 

  • SPL UNCLASSIFIED SECTION

    TEAT  DIP CONCENTRATE

  • WARNINGS

    DANGER

  • 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  SKIN  IRRITATION.

    CAUSES  SERIOUS  EYE  DAMAGE.

    FOR  FARM  AND  INDUSTRIAL  USE  ONLY

    PREVENTION:  Wear  protective  gloves.  Wear  eye  or  face  protection.  Wash  hands  thoroughly  after  handling.

    FIRST AID / RESPONSE: 

    IF  ON  SKIN:  Wash  with  plenty  of  water.  If  skin  irritation  occurs:  Get  medical  advice  or  attention.  Take  off  contaminated  clothing  and  wash  it  before  reuse.

    IF  IN  EYES:  Rinse  cautiously  with  water  for  several  minutes.  Remove  contact  lenses,  if  present  and  easy  to  do.  Continue  rinsing.  Immediately  call  a  POISON  CENTER  or   doctor.

  • STORAGE AND HANDLING

    STORAGE:  Store  locked  up.                                                     

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

  • SPL UNCLASSIFIED SECTION

    EMERGENCY  TELEPHONE  NUMBER  (CareChem 24)  1-215-207-0061                                                                                   Toll  Free:  1-866-928-0789

  • ACTIVE INGREDIENT

    ACTIVE  INGREDIENTS  (when  diluted  1:3):  Glycerol  Monolaurate 0.25%, Lactic  Acid 2.5% 

  • INACTIVE INGREDIENT

    EMOLLIENTS  (when  diluted  1:3):  7.5%

  • SPL UNCLASSIFIED SECTION

    NDC: 17307-3022-3

    NET CONTENTS:  55 GALLON (208.2L)

    Use  Aura  Concentrate  effectively  to  reduce  the  spread  of  mastitis  causing  organisms.   Aura  Concentrate  is  suitable  for  use  as  a  pre  or  post  dip.

  • INSTRUCTIONS FOR USE

    DIRECTIONS:

    IMPORTANT:  CONCENTRATE  MUST  BE  DILUTED  WITH  CLEAN  WATER  PRIOR  TO  USE.  RECOMMENDED  DILUTION  IS  (1:3).  MIX  (1)  PART  AURA  TO  (3)  PARTS  OF  WATER.  MIX  WELL  PRIOR  TO  USE.

    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

    image description

  • INGREDIENTS AND APPEARANCE
    AURA CONCENTRATE 
    lactic acid teat dip solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17307-3022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERYL LAURATE (UNII: Y98611C087) (GLYCERYL LAURATE - UNII:Y98611C087) GLYCERYL LAURATE0.01 kg  in 1 kg
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID0.12 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17307-3022-119 kg in 1 CONTAINER
    2NDC:17307-3022-257 kg in 1 DRUM
    3NDC:17307-3022-3208 kg in 1 DRUM
    4NDC:17307-3022-41003 kg in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/16/2024
    Labeler - AgroChem USA, LLC. (118336116)
    Registrant - AgroChem USA, LLC. (118336116)
    Establishment
    NameAddressID/FEIBusiness Operations
    AgroChem USA, LLC.118336116api manufacture, manufacture, analysis, label, pack