UNITED STATES ENVIRONMENTAL PROTECTION AGENCY€¦ · The Agency in accordance with the Federal...

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D C 20460 0001 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION M \ 3 2012 Kathy Skates Y TEX Corporation 1825 Big Horn Ave PO Box 1450 Cody WY 82414 Subject Amended Reregistration Label Product Name Equanimity Insecticide Kit EPA Registration Number 39039 13 EPA Decision Number 413491 Dear Ms Skates The Agency in accordance with the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) as amended has completed reviewing all of the information submitted with your application to support the reregistration of the above referenced product in connection with the Permethrm RED and has concluded that your submission is acceptable NOTE This product is not being reregistered under sections 3(c)5 and 4(g) of FIFRA at this time In addition please note that the record for this product currently contains the Confidential Statements of Formulation (CSFs) listed below Any previously dated CSFs are superseded Basic CSF dated March 11 2010 A copy of your label stamped Accepted is enclosed along with copies of the acute toxicity and product chemistry reviews completed for the subject product Products shipped after 12 months from the date of this amendment or the next printing of the label whichever occurs first must bear the new revised label Your release for shipment of the product bearing the amended label constitutes acceptance of these conditions If these conditions are not complied with the registration will be subject to cancellation in accordance with FIFRA sec 6(e) Iof2

Transcript of UNITED STATES ENVIRONMENTAL PROTECTION AGENCY€¦ · The Agency in accordance with the Federal...

Page 1: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY€¦ · The Agency in accordance with the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) as amended has completed reviewing

UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON D C 20460 0001

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

M \ 3 2012

Kathy SkatesY TEX Corporation1825 Big Horn Ave PO Box 1450Cody WY 82414

Subject Amended Reregistration LabelProduct Name Equanimity Insecticide KitEPA Registration Number 39039 13EPA Decision Number 413491

Dear Ms Skates

The Agency in accordance with the Federal Insecticide Fungicide and Rodenticide Act(FIFRA) as amended has completed reviewing all of the information submitted with yourapplication to support the reregistration of the above referenced product in connection withthe Permethrm RED and has concluded that your submission is acceptable

NOTE This product is not being reregistered under sections 3(c)5 and 4(g) of FIFRA at this time

In addition please note that the record for this product currently contains theConfidential Statements of Formulation (CSFs) listed below Any previously dated CSFs aresuperseded

• Basic CSF dated March 11 2010

A copy of your label stamped Accepted is enclosed along with copies of the acutetoxicity and product chemistry reviews completed for the subject product Products shippedafter 12 months from the date of this amendment or the next printing of the label whicheveroccurs first must bear the new revised label Your release for shipment of the product bearingthe amended label constitutes acceptance of these conditions If these conditions are notcomplied with the registration will be subject to cancellation in accordance with FIFRA sec6(e)

Iof2

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If you have any questions about this letter please contact Julie Chao at (703) 308 8735orchaojulie@epa gov

Sincerely

-Richard J GebkenProduct Manager (10)Insecticide BranchRegistration Division (7504P)

Enclosures Label stamped AcceptedAcute Toxicity Review dated November 15 2011Product Chemistry Reviews dated December 5 2011

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ACCEPTED

Outs.de Front Panel of, Fungicide,

and Rodenticide Act as amended for thepesticide registered under

EPA ReB No 31&31-I3

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CONTENTS

1 4oz Bottle 107 Permethnn

1 Plastic Container to ChargeFoam Applicator

4 Protective Plastic Gloves

USAGE

EASY AS

Wearing protectiveglove pour desireddose into container

Place foam applicator in chargedcontainer then

applicator

compress foam todistribute dose in

Apply desired dose to the appropriatelocation depending on the pest tobe controlled

FOR GENERAL PEST CONTROL Apply Equanimity as a whole bodywipe once every 7 days at the Maximum Rate of 6 ml/200 Ibs body wt(Max Dose=30 mis/horse) For improved results against specific pests followthe instructions on the back of the box Read entire label before each use

Inside Front Panel of Box

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Insecticide foi HorsesPRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS ANDDOMESTIC ANIMALS

CAUTIONA oid contacl w Ih skin yeso cloth ng Washtho oughly wilh soap ano water after handling

FIRST AIDIF SWALLOWED1mm d I ^ call p t I dDo I d mt 9 I t Id I d sobyap sI I i o d 1Do 01 g y liq id I th p rsoIX) t g ylfi by m It t dr *o usp

N I t Phy G t p I I md III I M yp^p tonp mo kaz rd H th p d t I

I I I th y h I! g p son co I 1 g g fI tm t Y m y I 0 CO ta t I 800 2W 1924 (CHEMTELINC f m rg cy m d .a! t 1m t form t

PHYSICAL AND CHEMICAL HAZARDSDo lot use o sto e near heat o open flame Do oluse tins product in or on electrical equ pmenl due tothe pobs b I ty of shock ha^a d

ENVIRONMENTAL HAZARDSTh s product s extremely lox c to aqu tic organismsnclud ng I sh dnd In e tehrates To n otpr the

v onmenl do not alio / pest c des to enter o oun of to slo d al s dra nag J Iches g Iters or

surface waters Apply ng th s p oduct in cairn weathewhen ra n is ot p erj t d lo th ne 124 hours willhelp to ensure that wi d or ram does not blow o w shpesticde off the i eatnei t area

STORAGE AND DISPOSALDo not contam ate wate food o feed by bio ageand di posalPesticide Storage and Sp II Procedures Storeupnaht at room temperature Avo d exposure toextreme temperatures In case of sp II o leakagesoak up w th an absorbent mater al such as sandsaw 1 jst ? rlh fuller s earth etc D spose of w thchemical wasteDisposalIf Empty Do not reuse this container Place in trashor offer for retycl ng f a a lableIf Partly Filled Call you local sol d wasie agency fordisposal nst net 01 Ne e place unused productdow i a iy indoo or outdoor dram

Insecticide KitINTEGRATED PEST MANAGEMENT (IPM)

Effective pest control on horses first requiresa basic understanding of the different pestsinvolved The preferred feeding site on theanimal breeding sites for immature stages andresting sites for the adults all must be consideredwhen designing an Integrated Pest Managementprogram (IPM) An IPM program should involveevery aspect of your horse facility starting withthe design and construction of the entire facility

The thre components of an 1PM program arechemical cultural and biological Insecticidesapplied directly to horses are an importantcomponent of chemical control and for certainpests the only practical strategy Cultural controlmeans removal of breeding sites for immaturestages and resting sites for adults Cultural controlalso includes the use of mechanical controlsuch as screens and air blast fans that preventflying insects from entering barns Biologicalcon rol means the protection and or release ofbeneficial insects This strategy requires theludicious use of premise insecticides

The enclosed label will tell you how to useEQUANIMITY as part of the chemical componentin an IPM program In addition it will help identifythe pests and list additional strategies to aid incontrol of pest problems To develop an effectiveintegrated Pest Management program contactyour local county Cooperative Extension Sen/iceoffice for assistance

EPA Reg No 39039 13EPA Est No 39578 TX 1Manufactured forTUTTLES HORSE CARE DIVISIONYTEXCorp 1825BigHornAve Cody WY82414

Left Side Panel of Box Right Side Panel of Box

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Read entire label before each useDIRECTIONS FOR USE

It is a violation of Federal Law to use this product In a manner inconsistent with its labeling

FOR GENERAL PEST CONTROL Apply Equanimity as a whole body wipe once every 7 days at theMaximum Rate of 6 ml/200 Ibs body wt (Max Dose 30 mis/horse) For improved results against thesespecific pests follow the instructions below Do not exceed Max Rate or Max Dose

MOSQUITOESMosquitoes apply 6 ml/200 Ibs body wtonce every 7 days as a whole body wipe

For improved control apply 3 ml/200 Ibs body wt

once every 3 4 days as a whole body wipe

HOUSE FLY ANDSTABLE FLYHouse ilies apply

1 ml/200 lbs> body wtonce every 3 4 daysto the face beingcareful to avoidgetting in the eyesStaole Hies apply 3 ml/200 Ibs body wt once every3 4 days to the legs belly and chest

BLACK FLIES AND EYE GNATS x^s&s^Black Hies apply 6 ml/200 Ibs body wt wKonce every 7 days to inside surface of theears Ihroat area and midline of the bellyEye gnats apply 1 ml/200 Ibs body wt once every 3 4days to the face being careful to avoid getting in the eyes

TICKS AND LICE

Ticks and lice apply 6 ml/200 Ibs bodywt once every 7 days as a whole bodywipe paying particular attention to those areas of thebody that are most heavily infested Depending on thespecies that may be between the front and hind legsin the mane and tail or in the ears for some species oflicks Lice should be eliminated by 3 weekly treatments

FACE FLY ANDHORN FLYFace flies apply

1 ml/200 Ibsbodywt onceevery 3 4 daysover the fa e being careful toavoid getting it in the eyesHorn Hies apply 6 ml/200 Ibs body wt once every 7

days as a whole body wipe For horn flies only apply30 ml as pour-on over the withers (do not nde for 24 hrs)

HORSE FLY AND DEER FLY

For both horse flies and deer flies apply 3 ml/200 Ibsbodywt once every 3 4 days over the whole bodypaying particular attention to where the flies arebiting Some species prefer to feed on certain areasof the body to others

HORSE BOT FLIESCommon hot flies apply 3 ml/200Ibs body wt once every 3 4 daysto the legs chest belly and flanks

Back Panel of Box

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Repels mosquitoes for up to 5 days including those thatmay transmit Equine Encephalitis and West Nile Virus

Kills ind repels Black Flies ind Ticks including thoseticks that may transmit Lyme Disease

Reduces Bot Fly eggs laid on horses tor up to 4 days

Precise dose directly from the container

Rain res/ifinf formulation

Top Panel of Box

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Outside FrontPanel of Box

EquanimityInsecticide Kit Box

Showing Front FlapPartially Open

Inside FrontPanel of Box

Equanimity Insecticide Kit BoxShowing Front Flap Fully Open

L of (I

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. \ Y \ \ T \ \ \ \ iInsecticidefo> Horses

ACTIVE INGREDIENTP th 10/OTHER INGREDIENTSt 90TOTAL 1CKUCfctar d« 4 ]os

KEEP OUT OF REACHOF CHILDREN

CAUTION

S TT C ED aI 10 REC UTI

NET CONTENTS tt\S(120ml)

Front Label on 4 fl oz Bottle

ACCEPTEDJUN 13 2012

Under the Federal Insecticide Fungicide,and Rodenticide Act as amended for the

pesticide registered under

-7 6£ [\ EPA Reg No

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BookletAttached to

Back of4fl ozBottle

PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS AND

DOMESTIC ANIMALS

CAUTIONAvodc t twlh k ey o cloth gWash tho o ghly th soap a d ate afteh til 0

FIRST AIDIF SWALLOWED

Imm d tely all po o c t I tod cto

Do ot d ce om t ng u I ss told t do soby a po o t I e te o dodo

Do otg e y lqudto thepesoDo not g a yth g by mo th to unconcio spe

N tetoPhysc Co tai spetole mdistl-lates M yposean sprat p e mo h dH e th p od t t lab I w th y

h II g p oil te o go gfo treatment You may also co t ct 1 800 2553924 (CHEM TEL INC} fo erne g ncy medcalt eatme t info mat o

PHYSICAL 4 CHEMICAL HAZARDSDo ot see st enea heato opeflame Do t th p od t n o oelect caleq pmentd e to the poss b I tyof shock h zadEPAR g N 3103913 EPAE I N 39578TXM I t d I T III H CDYTEXCop 182bBigHomA Cod»WY82414

ENVIRONMENTAL HAZARDSTh s p od ct s e t em ly to c to q at cogan ms did gf had vertebatesT p ote t the e o m t do not Howpe t c des to e te o to n off nto stormda s dra agedtches g Be so surfacewate s Apply g th s p oduct n calmwe the he a s ot p ed ct d fo thn xt 24 ho s II help to e u e that w do an does otblo or ash pest cide

ff th t eatme t a e Th s p si c de sh ghly t t be s e po ed to d ectt tm t bloom g p dDo t pplyth p d t II ttod ft to bloom gcopso eeds hiebees a e si g the t eatme t e

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PERSONAL PROTECTIVE EQUIPMENT (PPE)Appl ato d the ha die s must wea

Lo g slee e sh t d lo g p IsShoes pi s socks a dChem I e sta t glo es m de of t le o

eop e bbeUSER SAFETY REQUIREMENTS

Follow ma uf tu er's st ct o s fo clg/ma t g PPE If h t ct o fo

h bl s t d te ge I a d hot wateK p dw hPPEs p t l y fom the• dv

USER SAFETY RECOMMENDATIONSU h i d h h d b f t g d k gh e w g g g t b c o s g t h t l t

U sho Id m I th g/PPE mm d tly f p I de gets de The a hth ghly d p t cle loth gUse sho Id em I th g/PPE mmedtely ft h dl g th p od t W sh th

t d of gl b fo mo g As oop ssble hlh ghly a dcha ge nto

clea cloth g

READ ENTIRE LABEL BEFORE EACH USE

DIRECTIONS FOR USEIt s a olat o of Fede al la to se th sprod ct i a ma e co s ste t th tsI bel g F d ty h h mp

d Howl dryth ghtyW arp teclglo e provided Shake well before us gDo U tf al nde 12 weeks of age

F co 1 I fm q tbl k (I ffl es 1 ce & t ckAd tol ft blefl d

fl h flb tfl a deyg t

Apply ry7d y wh 1b dy w p w thf m ppl t toh rse a dpo etth M R t(6mlp 200

Ib body we ghtto M D f30 ml pe ml

FOB IMPROVED RESULTS AGAINSTSPECIFIC PESTS SEE INSIDE BOOKLETFOR MORE DETAILED DIRECTIONS ANDPRECAUTIONARY STATEMENTS

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©W gp led

f ill h b thdd th

P I I

\ Apply d dd t pp p t'I I d p d g th p It b

1 lid

To apply EQUANIMITY to foam appl catoloos n cap o e meas g chambe o lya d hold bottle p ght@ Wh le wea ng a p otecti e glo e

sq eeze bottle to f II h mb wthequ ed d s ge Remo e that cap

a dpo dosage totheplastcco t e p o d d

©PI c Ihef mapplc to (gaysdedow ) to the c t ne Place Iheappl cato and co ta e o aims rface a d p ess do Ihe

ppl t lo d st b te the p od cte e ly th o gh t fhe g ay foam

f^T) Apply the product to the ho se in thedes ed local ts body Do ote ceed M R te of 6 ml/200 Ibb dy wt p ho se pe week oM Do e fSOml p h pweek Replace the foam ppl cato

to the o ta e henf shed

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Equi Booklket 5 12_2_Booklet/READER Spreads Q 8/12 358PM Page // ? IJfHOUSE FLY AND STABLE FLY

H e fl e do ot bile but ca se a oyancebype tentf dng ndlheey s m i le a d u dsSt bl fl es a e e y agg ess e bloodfeed gfl s lhapa f Ibt They feedp m ly o the tow I g d ome-t me Ihe fl ks Ho ses see I eq e Bystomp ng the feet a e s ally be gattack d by t ble fl sBoth hou fl d t ble fl s b eed

de y g o ga mail Ho s II sII b d y m tt th g t tha

40 m t St bl fl p f mt of ma ea d eget to of mlm t e conte t

APPLICATION OF EQUANIMITYH e fl es apply 1 ml/200 Ib b dyw ght e e y 3 4 d y to the faceb g fit dg tt g they sStable fie pply 3 ml/200 Ib b dy

t o e e y 3 4 d y t t h l gbelly and chest

Add to alSt tege to Ad Contolofth Ho Fly dSt bl Fly

Elm t g s m y b eed g sles asposs ble s mporta t Remo e ma ebedd g and ottie o gan c matte at le st

e y 31 4 d y Release of pa as t casps that attack the p pal stag c be

be efc I

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FACE FLY AND HORN FLY

F efl do tbtebutfe dlk hfl dlh y m le dwo ds They a e s m l a s adpp a a Th I ed ng m

t t gth th t fth h flyths g g eate a noya ce

H fl s blood feed g f l e tak gs e I bl d me Is a day Th y b th Ifth e I h efly d e llyf d cl ste th body of th hB th f fl d h fl b d(eh d t bed ttl m e p tp ma lyo past es

APPLICATION OF EQUANIMITYF fl pply 1 ml/200 Ibs body wto ce e ery 3 4 d ys to th f be g

(It odg tt g t th yHo fl pply 6 ml/200 Ib b dywt

y 7 d y wh I b dyw pe Fo ho n fl e o ly pply 30 mlas p u o o e the w the s oe ry 2 weeks Do ot d f 24 h s

Add t I St t g t A d Co t olf theF eFlya dHo Fly

See you local co ntyCoop at eE t S g If t

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HORSE FLY AND DEER FLY

Hf~<%H fl e e I ge gg ess e bloodled g f l esw th yp nf Ibt Theyleedp im ly nthe e k back a d mpbut II b te ho ses a y h e cl d g

D fl e ge e ally m h sm lie thahorse fl es b t s m lar i appea a ce Theyt e ggess e blood feedeswthpai fulbte They feed p manly o the headade sb tw l lb tehosesa ywhee

I d g n d t h f l a k s B t h h f ld d fl es b ed t bott m la dd w ded areas Horse fl es a d dee

fl es ha e been mpl cated as Ihe p ma yeel r I q e I t a em

APPLICATION OF EQUANIMITYF b th h fl e d de flpply 3 ml/200 Ibs body wt o ce e ery

3-4 d y the whole body p y gpart cular attention to where the fl esa e b t g S me spec es p efe to feedo rt n fth b dy

Add t n I St teg t A d C t Iofth Ho se Fly and Dee Fly

Ho fie dde fl ome ofthm td f f Itp tsofhosestoc tolMechan cal t aps a e a lable to ed ed It pop I t s N th h s II

dee flescome sdeb Id gssopod gco edshelte c supply some! f d g hghp p I t f the e

P t

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HORSE BOT FLIES

H bot fl a e the adult si g s ofth e p s of st ma h bots wh h esero s tenalpa tes f hoses Thec mm b I fly (he m si p e ale fIh o ghoul the U S Its appea a ce ss m I r to th I ol a h n y bee It I ys itsI ght y How eggs o the fo elegs bellyfla ks and shoulde s of ho ses Aft

cubat o pe od of 7 10 days the eggsh tchwh I k dbytheh s Thla rae are p eked p on the tongue TheI va tta h to the stom hi g whthey o e te d e p ed t thef the f II w g p g o s mm tot tth If y I

APPLICATION OF EQUANIMITYCommon bot (lie apply 3 ml/200 Ibb dy wt once e ery 3-4 d ys to theleg ch t b lly d fl ks

Add t I St t g to A d Co t I(H s B IFI

Aft th f tkll gf th rse h Idb g e a b oad spe I m bol c de and

th Im If cont I f II t Iparas tes

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MOSQUITOES

Se eralspe ofm sq toes w IIle d nh Th f d t tyg ate t th late g d a lymor g altho gh they are ct eth o gh t th ght Th y may t m teq ee c phalts(sleep g ck e )

dW tNI sM q t b d t d gw tOld automob le t es ca s o a y oI th I h Id w t ca b e d la gen mb s of mosq toes L ge bod s oft d g w t h sw mp lagoo s

p d s a d b k t f l k s c n breedla ge n mbers of mosqu toes Ad Its e t

I II egetat on near feed ng a d b eedg t s

APPLICATION OF EQUANIMITYM q t pply 6 ml/200 Ib b dywt o ce e e y 7 days a wh le b dyw p Fo mp o ed ontrol pply3 ml/200 Ib b dywt ry3-4d y wh I b dy w p

Addit n I St t g t A d n C t olfM sq toe

Removal of all object th t Id h Idtag ant wate s c Heal to ed c g adult

pop I t R m I f t II gra ndeeds ea ho eb s dpasta h Ip du adult p pul t ons Ad It

mosq toes are alt acted to I ghls at ghts t rn lights off n ba s and stablesI st II g I ght y f m b Id gsn t d f o e d orways w II help alt actm squ toes away f om bu Id gs

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BLACK FLIES AND EYE GNATS

Bl kfl sae mall blood feeding liesthatfe d th derthe ecka d

lo gthemdl e f Ihe belly depe d go th pe es D g h gh p p I t sIhe ea s a b c me s e d it ledBlack II p d I g o es onIh chest and mdl e of the belly ausbte t t the r saliva and theyt m t the m f lar a of 0 ch ca

ematodesEye g t small fl th t f ed

d the c e of the ey

APPLICATION OF EQUANIMITYBlack fl es apply 6 ml/200 Ib bodyw t o c e e e r y 7 d y t df e of the ears throat a ea and m dI of the belly For mpro edre ultpply 3 ml/200 Ib b dywtery 3-4 d y

Eye g t pply 1 ml/200 Ib b dywt nee y 3 4 d ys o d theye be g ca f I ot to get p od ct inthe eye

Add! ISt t g t Ad CfBI kFI dEy G t

S y local co tyCoopeat eExt onServceag tfo t

t I

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TICKS AND LICE

T ks a e blood s ck g rth pods thatmay Iran mil d s s su h as Lym d se se The adult stages ha e e ghl legsTh a se e al d ff r nt p e h bit g ty fh bt t Th pth t th mo t p bl m to hth th tl e dl dh bt t T kha e f ur I fe stages egg la vae (seedt ks) ymph (y I g ) d d It Thseed t cks a e f equ tly f d I geIt f I th sa d Nymph a d

ad Its a e usually fou d d d llyL e e Iher s ck g (blood feed ng) orchew g (non bl od f ed ng} They et mtt dbyd t t tw th I t d

m I

APPLICATION OF EQUANIMITYTck a dL e pply6ml/200Ibsbody w t o c e e y 7 d y sa wholeb d y w p p y g p r t I t t ttotho earea of the body th t em t h ly nfested Oepe d gothe sp th t m y b betw n thf t d h d l g t h m e dt I th f m p ft ks L e ho Idb Im ted by 3weekly t eatm t

Add t I St t g s to A d n C t I(Tck dL

Keep gh s s to l tckh bt t d/oIckhabtal educto ca help educe you

nd yo r horses expos re to t cks Fenceh o t f o d d a K e p f e eow a d othe a eas of the pastu e le

of t II g a s we ds a d b u h T p t ty ho t m I p e t c t t withnfested ho ses and e am e II w h re

fo festal o

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STORAGE AND DISPOSALD t t m te te f d fe dbysto g d po IP t d St rag d Sp IIP oc dSt re up ight at room tempe atu e A o de pos e to ext eme temp rat e I ca

f pll I kag soak pwriha absorbentmat a! such as sand sa d st earth f Her1

rth t Dsp seofwthchemcal asteD p IIf mpty D not th CO t Pla

t h « f ecy I g faalableIf Partly F lied Cally I Is I dwa tage cy fo d sposal st ct o s Ne eplace sed product do na yi doo ooutdoo da

NOTICE OF WARRANTYYTEXC p t k ly fh t b I ty f t f y p p th rwxp d pled g t h p o d t! w h h x t d b y d t h I Ihp d t d I ondt cc d thth t t t d th I b I d y

I I d t pi t I p d I ly

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