received 2 72dijl€¦ · thcsubmitted efficacy data (mrid no. 471145-01) support the use of the...

13
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 Ms. April Zambelli-Weiner Senior' Scientist· for, Sterilex Corporation 11409 Cronhill Drive Suite L Ownings Mills,MD 21.117 A\IG·l·St007. OFFICE OF PREVENTION, PESTIC.IDES AND ", TOXIC SUBSTANCES RECEIVED AUG 2 72DIJl 'Subject: Sterilex Ultra DisinfectantCleaner Solution 1 EPA RegistrationNumber 63761-8 Your Amendment Dated ivhirch 17 th ; 2007 EPA Received Date March 30 th , 2007 The amendment referred to above, submitted in connection with registration under section 3(c)(7)(A) of the Federal Insecticide, Fungicide, Wld Rodenticide Act,.FIFRA, as amended, to add use sites, directiortsforuse, and additional labeling c1aims,·is Thcsubmitted efficacy data (MRID No. 471145-01) support the use of the product, Sterilex Ultra Disinfectant Cleaner Solution combined with Sterilex Ultra Cleaner Solution 2 and diluted in 10.0 ml of 400 ppm water as adisirtfectant with bactericidal activity against Resistailt on hard. non- porous surfaces in the presen<;e.of a 5% organic soil load for a contact time of 10 minutes at 20 degrees Celsius. . Thesubmi lted efficacy data (MRID No.4 71145-01). support the use· of the product, Sterilex Ultra Cleaner Solution I combined withSterilex Ultra Cleaner Solution 2, and diluted in i 0.0 mr of400ppmhard water, as fungicide against Aspe.rgillus niger, when 'used>on hard, non-poroussuifaces foracohtact time of 10. minutes in the presence of 5% organic soil loadat room temperature 20 degrees Celsius. The proposed label claims thatthe product, Sterilex Ultra Disinfectant Cleanet'Solution 1 (one part) combined wilhSterilex Ultra Disinfectant Cleaner Solution 2(one part) and diluted in 10 parts of water, removes biofilm from denial unit lines, are acceptable. that the species name of these organisms (Salmonella choleraesius) has been changed by ATCC. The new designation of this organism is The change is effective immediately? andshouldhe.userl for all subsequent references to this organism in the future.

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Page 1: RECEIVED 2 72DIJl€¦ · Thcsubmitted efficacy data (MRID No. 471145-01) support the use of the product, Sterilex Ultra Disinfectant Cleaner Solution combined with Sterilex Ultra

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

Ms. April Zambelli-Weiner Senior' Scientist· for, Sterilex Corporation 11409 Cronhill Drive Suite L Ownings Mills,MD 21.117

A\IG·l·St007. OFFICE OF

PREVENTION, PESTIC.IDES AND ", TOXIC SUBSTANCES

RECEIVED AUG 2 72DIJl

'Subject: Sterilex Ultra DisinfectantCleaner Solution 1 EPA RegistrationNumber 63761-8 Your Amendment Dated ivhirch 17th

; 2007 EPA Received Date March 30th

, 2007

The amendment referred to above, submitted in connection with registration under section 3(c)(7)(A) of the Federal Insecticide, Fungicide, Wld Rodenticide Act,.FIFRA, as amended, to add use sites, directiortsforuse, and additional labeling c1aims,·is acc~ptable.

Thcsubmitted efficacy data (MRID No. 471145-01) support the use of the product, Sterilex Ultra Disinfectant Cleaner Solution combined with Sterilex Ultra Cleaner Solution 2 and diluted in 10.0 ml of 400 ppm hard~ water as adisirtfectant with bactericidal activity against Staphylo~occusaureus":Methidllin Resistailt on hard. non­porous surfaces in the presen<;e.of a 5% organic soil load for a contact time of 10 minutes at 20 degrees Celsius. .

Thesubmi lted efficacy data (MRID No.4 71145-01). support the use· of the product, Sterilex Ultra Cleaner Solution I combined withSterilex Ultra Cleaner Solution 2, and diluted in i 0.0 mr of400ppmhard water, as fungicide against Aspe.rgillus niger, when 'used>on hard, non-poroussuifaces foracohtact time of 10. minutes in the presence of 5% organic soil loadat room temperature 20 degrees Celsius.

The proposed label claims thatthe product, Sterilex Ultra Disinfectant Cleanet'Solution 1 (one part) combined wilhSterilex Ultra Disinfectant Cleaner Solution 2(one part) and diluted in 10 parts of water, removes biofilm from denial unit lines, are acceptable.

Pl~asenote that the species name of these organisms (Salmonella choleraesius) has been changed by ATCC. The new designation of this organism is Salmonellaenterica~ The change is effective immediately? andshouldhe.userl for all subsequent references to this organism in the future.

Page 2: RECEIVED 2 72DIJl€¦ · Thcsubmitted efficacy data (MRID No. 471145-01) support the use of the product, Sterilex Ultra Disinfectant Cleaner Solution combined with Sterilex Ultra

A stamped copy of the labeling is enclosed. Submit three (3) copies of your final printed labeling before distributing or selling the product bearing the revised labeling.

C Submit and/or cite all data required for registration /reregistration of your product under FIFRA section 3(c)(5) when the Agency requires all registrants of similar products to submit such data.

If the above conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your release for shipment of the product bearing the amended labeling constitutes acceptance of these cOi1ditions.

If you have any questions concerning this letter, please contact Karen M. Leavy-Munk at (703)-308-6237. .

Sincerely, .

Marshall Swindell Product Manager 33 Regulatory Management Branch I Antimicrobial Oi vision(7 51 OP)

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Sterilex Ultra Disinfectant Cleaner Solution 1 This is paiioneofa two-part product This productmllst be used withSterilex.UltraActivator Solution. Please consult the directions. for use for specific instructions.

One.,Step Disinfectant - Cleaner I

Staphylocidal -Pseudomonacidal - Salmonellacidal - Listericidal - \lirucidal-~R~i1Q~~ji,MI@~~!

~ffiGtiY;~ig~f[~~LooiAAf9~in;:prQg[Q'ng~m~!~§

Kills/inactivates:

Active l l1gredients: n-Alkyi(C1268%, C14 32%} dimethy1ettlylDenzyiammonium chloridE! n,:-Alkyl (C14 60%, C16 30%, C12 5%, C18 5%)'dime~ylbel'lzyl ammoniuinchloride Hydrogen peroxide

Inert Ingredients: TOTAL:

KEEP OUT OF REACH OF CHILDREN 'DANGER

100.00%

SEE 'SIDE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENT$

FIRST AID

3:'00% 3.00% 6.30%

87.70%

IF IN EYES: Holdeye open and rInse slowly 'and gently with water for 15,... 20 minutes. Remove contacUenses; if present,afterthe first 5 minutes, then continue rinsing eye. IF ON SKIN OR CLOTHING: Takeoff contaminated clothing. Rinse skin immediately with plenty of water for 15,-' 20 lTlinutes. IF INHALED: Move person to fresh air. Ilperson is,not breathing, call 911 or an ambulance, then give·artificial respiration, preferably by mouth-to-mouth, if possible: Calla poison control center or doctor fOr further treatment ~~re ' IF SWALLOWED: Call a poison control centetor doctor immediatelyfortreatmentadvice. ttave person sip a glass of water if able to swallow. Do not induce· \lQmiling· unless told to do So by the poison con~rol center or doctor. Do notgive·ahything by mouth toan' un~()nsciousperson.

, ~Jt%ff~::' Call a Poison Control Center or doster for treatment advice. Have the product contctineror label with yoo when calling a Poison Control Center or do~or or going for treatment.

'NOTE TO PHYSICIAN: probab!~ !TIucosal damage may contraindi~~ the use of g"astric lavage.

EPA Reg. No. 63761-8 EPA Est. No. 4875-NJ-901

Net Contents (insert'container size hete)

Sterilex UI.tta Disinfectant Cieaner Sot~1rn 1 ~f~1.61.8} Revised March 17,' 20071 Page 1 of 1,1

Page 4: RECEIVED 2 72DIJl€¦ · Thcsubmitted efficacy data (MRID No. 471145-01) support the use of the product, Sterilex Ultra Disinfectant Cleaner Solution combined with Sterilex Ultra

Manufactured by Sterilex Corporation 11409 Cronhill Drive Suite L Owings Mills, MD21117 'phone 1-800-51t-165~, fax 410-581-'8864

(, ~ ~ J.-.Daaid: in ..... "

AUS232007 O'IIdefthe.~i~ .. r\mgiOdti (JLt1:"',\( ... ~ i'ldas

~:~~~.~I~~~~1~1~T!:~~1SMESTJC ANJMA~S'~ ';:~=~No.r.o31-&I-t DANGER: Corrosive. Causes irreversible eye damage and skin' burns. May b~fatal if inhaled. Harmful if swallowed or absorbed through skin. Do not getin eyes,. on skin or on clothing. Do not breathe vapor orsprCiY mist. Wear goggles andlor face shield, protective clothing and rubber gloves When handling. Wash theroughlywith soap and water after handling and before eating, drinkirigor using tobacco. Remove.contaminated'clothingand wash clothing before reuse. Prolonged or freC!uentlyre~ated skin contact may cause allergic reactions in some individuals.

ENVIRONMENtAL HAZARDS

This pesticide 'is toxic to fish. Do not discharge effluent containi"g thlsproductinto lakes, streams; ponds, estuaries, oceanS o~ other waters unless in accord~ncewit~ t.he.requiremehts of a Natianal Pollutant Discharge Elim,inationSystem (NPDES) permit and theperrriitti.ng authority has been'notified in.writing prior to discharge. Do r.tot discharge effluent-containing this product to seVier systems without previously notifying the 10~1 sewage treatment plaritauthority. For guidance, contact your State Water Board or Regional Qffice of the EPA

PHYSiCAL AND CHEMICAL HAZARDS

When exposed to.fire, Sterilex Ultra Dlsinfe~tant Cleaner, SolutIOn 1 may release oxygen and oxides of carbon andlor nitrogen. .

STORAGE AND DISPOSAL

Do no.tcontaminate ..vateri food, or feed by storage ordisposcll.

PESTICIDE STORAGE: Keep productin closed original container whennotin use.StQre in a coel ar¢a away from potential sources of heat, open flames, sunlight ar other qhemicals. Productshould be stored beIQw90°F, .PESTICIDE DISPOSAL: Pesticide wastesareacuteIY.hazardous. Improper disposal pf· exc:ess. pesticide, spray or mixture or rinsate is a violation of Federal Law; IftlJese wastes cannot be disposed of by use according to label instructions, contact your State Pestic:ideor Environmental CohtrolAgency; or the~Hazardous Waste representative

·at the nearest EPA Regional Office for guidance. . . CONT AINERDISPOSAL: C()mpletely empty and triple rinse container . into application equipment. Dispose of er:nptycontainer in a sanitary landfill,or if allowed by state and local authorities; by burning. If burned, stay out of smpke.

DIRECTIONSFQR USE

It isa violation of ~ederal Lawto use this praducfin a manner inconsistent with its labeling.

Sterilex Ultra Disinfectant Cleaner S,oluti9n1 is part one of a tWo~part product. This product mustA~\lVAYS:be used in conjunction with SterilexUltraACtivator Solution. '

DISINFECTION Sterllex Ultra Disinfectant Cleaner Solution 1, when mixed witli Sterilex, Ultra Activator Solution, is a one-step, hospital-use disinfectant at 12,8 flr;9~,(each, Solution 1 & Solution 4) per gallon of water (1:1: 10), Bactericidal according to the current AOAC Use.;Dilution Test Method modified in the presence of40P ppm hard water plus 5% organIc serum against: ' .

(~~1i:J , ' Pseudomonas aeruginosa '(Pseuddmonas)(ATCC#15442) Staphylococcus aureus (Staph)(ATCC#6538) Sta""fi'·10001!l!!Usl'iufiJusjf!~Meffficj(ltn'''ResIStantt'Aii1t(:f~Q9lWM.8$AJ """.: .. if!,,, ~ .. ",,".~."",,,, .. ".w"'''''''''C" .... c,, ......... ",Jlllb ... , .. , .. c,c .... '"'''' ",., .... J .. ,'", .. ". ''''''''~'''''''''''~'~'''A' ,', ... , .. , ',' " ... ,.)X . ... , ... S~/monet/a chole,raesuis (Salmonel1a)(A TCC# 1.0708) Escherichia coli 0157:H7 (ATCC# 35.1.50) Listeria monocytogenes (A TCC# 19111) SterilexUltra Disinfectant Cleaner,SQh,Jti9n 1 (63761-8) Revised March 17; 20071 Page20f 11

yJ~;:::.~

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SPOILAGE ORGANISMS ,Sterilex Ultra Disinfectant Cleaner Solution, 1, when mixed with Sterilex Ultra Activator 'Solution kills Zygosaccharomyces ballii on hard, inanimate surfaces it1 one step at 4 fl. oz. (each,Solution 1 & Solution 2) per' gallon of water (1: 1 :32) , according to the current AOAC Use~Dilution Test Method modified in the presence of 400 ppmhard water plus 5% organic serum. Apply as directed under disinfection.

VIRUSES Sterile~ Ultra Disinfectant Cleaner Solution 1, when mixed with Sterilex lJltr.a Activator Solution is effective against, Avialilnfluenza A (H3N2: Avian Reassortant) on hard,inanlmate surfaces in one step at2 fl. oz. (each, Soilltion 1 & Solution,2) per gsllonof water (1:te4), with a 5 minute, contact time in the presence of 400 ppm hard water and organic soil. Apply as direbted'underdisinfE?Ction. '

SterilexlJltraDislnfectant Cleaner Solution '1 ,when mixed with Sterilex Ultra. Activator Sqlutjqn, ' is' for use on washabie hard,nonporolJs surfaces in: hospitals, medicaland.dentaloffices, nursing hOITlf3~; l1ealtb,care facilities, ultrasonicba~s (ultr:asonic Cleaning uriif~),federally ihspectedfoodprocessing facilities, federally inspected meat and poultry plants, wineries; breweries,beverage mahufacturingfacilities, dairy farms; sWine ~rms, poultry and turkey farms, farm premises, hatcheries, refrigerated trucks, ke)inels,petanimal quarters, z,oos, pet shops, animal laboratories, veterinary facilities, animal care facilities, transportation terminals, l1ote,I5 and, motels, factories; bUSiness and office buildings, barber' shOps, salons, boats, 'ships, campers, trailers, mobile homes, homes, kitchens, bathrooms, household areas; cars, buses, trains, taxis, airplanes, restaurantS, bars, cafeterias, institutional kitchens, food preparation and storage areas, convenie fOod storage areas, public rest rooms, institutions, schools and colleges, athletic locker '

shower and bath exercise l'lI'lm,!'!nr

Sterilex Ultra D,islrifectant Cleaner S,olution1, when mixed with Sterilex Ultra Activator Solution,is for use on the following washable haro, ; nonporous Sllrfaces: ' !" ;~

Medical machines (x-r~y, MRls, CAT scanners), noncritical medical devices arid equipment s penetrate the body or contact the ,human 'bloodstream or mucous membranes); ",

Steam sterilizer water reservOirs, steam sterilizer water reserVoir tubing; "d;.,,""-"_l~,

~-,':d~ktas Water reservoir tanks, water reservoir pipes, tanks" and piping systems used in fOod processi=: lor tho~,

, , ~red under fl¥\Reg'~~/Jj Floors, walls, coui'ltertops, stovetops, sinks, appliances, refrigerators (exteriors), plastiC and other nonporou~J 11 ~ cuttiQg boarps and chopping blocks; coolers. ice chests; non residential:refrigeratorbins (exteriOrs) for meat, fruit, vegetable and egg; food processing eqiJipment(k,:pac equipment; il1jebtors, ,slicers, knives, steel mesh gloves; deb~ners! saws~ grinders, cutters, racks, dairy eqUipment, interlocking belts. 0lltsidesurfCices o{kitchen equipment, beer fermentation land holding 'tanks, brewery pasteurizers, win~ fermentation tanks, beverage dispensing equipment beverage transferlil1es"bottling or premix dispensing equipment); ,

D~inking water coolers, ice making maChini \, transfer line tubing, water lines. watering systems,farm animal nipple drinkers; ,~; I,

~'?:~ ~~

Cabinets, highchairs, garbage cans, garbag~ orageareas, refrigerated storage and display equipment (exteriors), tables, picnic tables (non-wooden and tint' sealed, ,or painted), outdoor furniture, chairs, desks, telephones,

Sterilex.LJltrEl Disinfectant'Cleaner SolutioI'"! 'H!>37~ ReVised ¥arch 17, 20071 Page 3 of 11

Page 6: RECEIVED 2 72DIJl€¦ · Thcsubmitted efficacy data (MRID No. 471145-01) support the use of the product, Sterilex Ultra Disinfectant Cleaner Solution combined with Sterilex Ultra

dO.orknobs.showerstalls. tubs and glazed tiles. whirlpool bathtubs. bathtubs, sinks, urinals, exterior toilet bowl surfaces. other bathroom fixtures;

Kennel runs,cages.; waterers andteederS, 'alJtoma~ic feeders, hauling equipment, dressing plants •. loading equipment. farrowing barns and related areas(nurSery;blocks~crE').apare.as),chutes,feed racks! mangers, troughs. fountains and waterers. forks. shovels,scraper,s.l?arns. pens.stan~h facilities and fixttiresoccupiedor traversed by al1imals, hatchery areas (egg receiving and. hOlding,setterroofTl, t(aY dumping; chick holding, processing and loading). trays, buggies, racks, egg flats, poultry Quildings. ceilings, sidewalls and floors; drinkers and other poultry ~hollse related equipment;

Coils and drain pans of air conditioning and refrigeration equipment and heat pumps, conductive flooring;

Nonporous salon/barber tools' and instruments (combs. brushes, scissors,blades, pedicure and manicure instruments, pedicure and manicure tub*,);

Hard. nonporous' surfaces, listed on this label; that are made of nietal, stainless steel, .glazed porcelain, glazed . ceramic, sealed ·stone. ~ardfibergla~ (bathtubs, tubs, shower stCills,an(:l sinks), plastic(~uch as polystyrene, polypropylene)" glaz.adporceiaintiling,enameled surfaces,fiilished/sealedand painted woodwork; finished floors, Formica®, vinyl and plastic upholstery;

.ffprmw~f~~(Qt\$1f~~~;Pl1)Yf!ij~ru!f!lJ~;ii!i!fm!~11

;~~rm1ii~J~;fP~rilf~~!!~(n~im~mi~Tt@i1~tl9p

:~·";nTiUjateaimr:leffeetivi'7f8rm,;·'remise'1use. ",Jt.,"''',., ........... " .. , ...... " .. ~ .. «~=, .. , ...... "" ... P " ........ ,." .. , """"",,,.'

B~~W'ka,M~;J~~r9[m~!~~ff~r~lmUa,~Wii~tijn(ra~p~~~i

Sterilex Ultra Disinfectant Cleaner Solution 1 (63761-8) . \

Revised March 17. 2007 {Page 4 of '11

Page 7: RECEIVED 2 72DIJl€¦ · Thcsubmitted efficacy data (MRID No. 471145-01) support the use of the product, Sterilex Ultra Disinfectant Cleaner Solution combined with Sterilex Ultra

Rrevents:andi'su'"'' 'ressesi~or-matiOn~ofY6Iofilmlinil(f"~ntai7'"ni{:water;ljjnes .'~4 .. """ .... ~,L, .•.• •. "".PP .• ", .... " ""_~;"" ..... " ' . '"<'-''''''' , .. "., .. ,@", .. § .. "",\l!I"" .. ,. , .. , .......... ,i~,..... "

~~tl§llQiani6t~~(rrl§

Mi(nUijnS'rijerntaPunit:watei;ifne:~fftuent~water;:<500YCt'Uiml v ___ ~",,,,,~,.. ,_' ....... _,"".".. ," ~"~,,,.,-• .,.<~,.,_.r _ . " ., >"<>,,v ___ !ii!!J"'':»'''''~''d~''''-' , ",.~,';""'."",....~h-..;-,.. .• ~ ; __ ';)~-'_'''''.,...>:$"_~,.",,",,<,,"»,,,

DISINFECTION IN HOSPITALS, ,MEDICAL OFFICES, DENTAL OFFICES, DENTAL OPERATORIES, NURSING HOMES AND OTHER HUMAN HEALTH CA~E FACILITIES: .

NOTE: This product is not to be used as a termioaJ sterilantlhighlevel disinfectant on any !)urface or instrument that (1) is introduced directly into the human body,either'into orh; cOntact with the bloodstream or normally sterile areas of the body" or '(2) contacts intactmucous,m~mbranes butwhich doesnot:ordinarily penetrate the blood barrier or otherwise enter normally sterile areas onhe body. This product maY,be used to pre..clea,n or decontaminate critical or semi..criticalmedical devices prior to sterilization or high-level disinfection.

APPLICATION INSTRUCTIONS: Sterilex Ultra Disinfectant Cleaner Solution {,(63761-8) Revi$ed March 17. 20071 Page 5 of 11

Page 8: RECEIVED 2 72DIJl€¦ · Thcsubmitted efficacy data (MRID No. 471145-01) support the use of the product, Sterilex Ultra Disinfectant Cleaner Solution combined with Sterilex Ultra

1) Add 12.8 fl. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and 12.8 fl. oz. of Sterilex Ultra Activator Solution to 1 gal. tap water inan appropriate plastic container and stir. 2) Thoroughly wet surfaces with use-solution by pouring, wiping, brushing, scrubbing, spraying with a coarse trigger sprayer, sponging, using a clean in place (CIP) system, pumping it through the system, drawing it through the system or mopping. 3) Allow surfaces to remain wet for at least 10 minutes 4) Rinse all surfaces thoroughly with a potable water rinse.

PRECLEANINGINSTRUCT10NS (OPTIONAL STEP): Although Sterilex Ultra Disinfectant Cleaner Solution 1 provides one-step cleaning and disinfection, precleaning may be desired for some surfaces in certain cases. 1) Prepare a precleaning solution by adding 3 - 6 fl. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and an equivalent amount of Sterilex Ultra Activator Solution to 1 gal. hot tap water in an appropriate plastic container, depending on the level of gross filth to be precJeaned. 2) Clean surfaces with precleaning solution by pouring, wiping, brushing, scrubbing, spraying with a coarse trigger sprayer, sponging. immersing, using a clean in place (CIP) system, pumping it through the system. drawing it through the system or mopping. 3) Rinse all surfaces thoroughly with a potable water rinse.

INSTRUMENT PRE-SOAK: For use as an instrument pre-soak, prepare a solution by adding 12.8 fl. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and 12.8 flo oz. of Sterilex Ultra Activator Solution to 1 gal. tap water in an appropriate plastic container and stir. Immerse instruments completely and allow to soak for 10 minutes. Rinse all surfaces thoroughly with a potable water rinse. Instruments must undergo high-level disinfection or sterilization following pre-soak treatment.

DISINFECTION IN ULTRASONIC BATHS:

ACCBP'tEO with cofl!MD!fS

·inFJ'A1stter Dcmid: NOTE:' . AUG 2 3 2.007 Use Sterilex Ultra Disinfectant Cleaner Solution 1 to disinfect hard nonporous non~~~patible with Ultrasonic Cleaning Units. ~.andRodE)n~Actas

nded.IOJ tho ~1icl&n, APPLICATION INSTRUCTIONS: _redUndCT'::Pi\.P'1'~' 1) Pre-clean heavify soiled objects following the PRECLEANING INSTRUCTIONS below. " .~/ r.~t -' . 2) Add 12.8 fl. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and 12.8 fl. oz. of sttt~i~ Ultra AC ivator Solution to 1 gal. tap water in an appropriate plastic container and stir. 3) Pour fresh use-solution directly into bath chamber. 4) Place objects into unit and operate for a minimum of 10 minutes, according to the manufacturer's directions. 5) Remove objects and wash with sterile water (sterile water for injection) or allow to air dry. 6) Prepare fresh solution for each use.

PRECLEANING INSTRUCTIONS (OPTIONAL STEP): Although Sterllex Ultra Disinfectant Cleaner Solution 1 provides one,:,step cleaning and disinfection. precleaning may be desired for some surfaces in certain cases. 1) Prepare a precleaning solution by adding 3 - 6 f1. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and an equivalent amount of Sterilex Ultra Activator Solution to 1 gal. hot tap water in an appropriate plastic container, depending on the level of gross filth to be precleaned. 2) Clean surfaces with precleaning solution by pouring, wiping. brushing. scrubbing, spraying with a coarse trigger sprayer, sponging, immersing, pumping it through the system, or drawing it through the system. 3) Before disinfecting rinse all surfaces thoroughly with a potable water rinse.

DISINFECTION OF FOOD PROCESSING EQUIPMENT AND HARD SURFACES IN FOOD PROCESSING FACILITIES, BREWERIES, WINERIES AND OTHER BEVERAGE MANUFACTURING FACILITIES, RESTAURANTS, BARS, CAFETERIAS, INSTITUTIONAL KITCHENS, CONVENIENCE STORES FOOD PREPARATION AREAS, FOOD STORAGE AREAS AND FOOD SERVICE AREAS:

NOTE: Before use in federally inspected meat and poultry food processing plants and dairies. food products and packaging

Sterilex Ultra Disinfectant Cleaner Solution 1 (63761-8) Revised March 17. 20071 Page 6 of 11

Page 9: RECEIVED 2 72DIJl€¦ · Thcsubmitted efficacy data (MRID No. 471145-01) support the use of the product, Sterilex Ultra Disinfectant Cleaner Solution combined with Sterilex Ultra

materials must be removed from the room or carefully protected. Follow all applicable local health and sanitation codes for sanitizing food processing equipment post-disinfection.

APPLICATION INSTRUCTIONS FOR SURFACES: 1) Remove gross food particles and soil from all articles using a pre-flush, or pre-scrape and, if necessary, presoak. 2) Add 12.8 fl. oz. of Sterllex Ultra Disinfectant Cleaner Solution 1 and 12.8 fl. oz. of Sterilex Ultra Activator Solution to 1 gal. tap water in an appropriate plastic container and stir. 3) Thoroughly wet surfaces with use-solution by pouring, wiping, brushing. scrubbing, spraying with a coarse trigger sprayer, sponging. immersing, using a clean in place (CIP) system. pumping it through the system, drawing it through the system or mopping. 4) Allow surfaces to remain wet for at least 10 minutes 5) Rinse all surfaces thoroughly with a potable water rinse.

PRECLEANING INSTRUCTIONS (OPTIONAL STEP): Although Sterllex Ultra Disinfectant Cleaner Solution 1 provides one~step cleaning and disinfection, precleaning may be desired for some surfaces in certain cases. . 1) Prepare a precleaning solution by adding 3 - 6 fl. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and an equivalent amount of Sterilex Ultra Activator Solution to 1 gal. hot tap water in an appropriate plastic container, depending on the level of gross filth to be precleaned. 2) Clean surfaces with precleaning solution to by pouring, wiping, brushing. scrubbing, spraying with a coarse trigger sprayer, sponging, immersing, using a clean in place (CIP) system, pumping it through the system, drawing it through the system or mopping. 3) Before disinfecting rinse all surfaces thoroughly with a potable water rinse.

. AC~ APPLICATION INSTRUCTIONS FOR TRANSFER LINES: vrithVVPJ.l"o~"A"'" 1) Add 12.8 fl. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and 12f1a~~:Ultra Activator Solution to 1 gal. tap water in an appropriate plastic container and stir. . "3 1001 2) Introduce use solution into transfer lines and tanks. . AUG' . 3) Soa,k or circula~e use solution for at least 10 minutes. UDderthe.~nfJ::'~~=\ct as 4) D~aln transfer hnes.. . ~ lot lh!l';~>~~;;i!J.s. 5) Rinse all sunares thoroughly with a potable water nnse. ~ trf' "'''' ,k

DISINFECTION OF VETERINARY FACILITIES, ANIMAL CARE FACILITIES, ANIMAL LABORATORIES, ZOOS, PET SHOPS, KENNELS AND ANIMAL QUARTERS, FARM AND DAIRY FARM PREMISES, SWINE PREMISES, FARM AND DAIRY FARM PREMISE EQUIPMENT, SWINE PREMISE EQUIPMENT.

1) Remove all animals and feed from premises, vehicles, and enclosures. 2) Remove aU litter and manure from floors, walls and surfaces of barns, pens, stalls, chutes, and other facilities and fixtures occupied or traversed by animals. 3) Empty all troughs, racks, and other feeding and watering appliances. 4) Thoroughly clean all surfaces with soap or detergent and rinse with water or follow PREClEANING INSTRUCTIONS below. 5) Saturate all surfaces with a solution prepared by adding 12.8 fl. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and 12.8 fl. oz. of Sterilex Ultra Activator Solution to 1 gal. tap water in an appropriate plastic container and stirring. 6) Thoroughly wet surfaces with use-solution by pouring, wiping, brushing, scrubbing, spraying with a coarse trigger sprayer, sponging, using a clean in place (CIP) system, pumping it through the system, drawing it through the system or mopping. Immerse all halters, ropes, and other types of equipment used in handling and restraining animals, as well as forks, shovels, and scrapers used for removing Utter and manure. 7) Allow surfaces to remain wet for at least 10 minutes 8) Rinse all surfaces thoroughly with a potable water rinse. 9) Ventilate buildings, cars, boats, and-other closed spaces. Do not house livestock or employ equipment until treatment has been absorbed, set, or dried. 10) Thoroughly scrub all treated feed racks, mangers, troughs, automatic feeders, fountains, and waterers with soap or detergent. and rinse with potable water before reuse.

APPLICATION INSTRUCTIONS FOR TRANSFER LINES:

Sterilex Ultra Disinfectant Cleaner Solutjgr 1 (63761-8) ."; ;~ ;,'

Revised March 17,20071 Page 7 of 11

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1) Add 12.8 fl. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and 12.8 fl. oz. of Sterilex Ultra Activator Solution to 1 gal. tap water in an appropriate plastic container and stir. 2) Introduce use solution into transfer lines and tanks for watering systems and nipple drinkers. 3) Soak or circulate use solution for at least 10 minutes. 4) Drain transfer /lnes and tanks. 5) Rinse all surfaces thoroughly with a potable water rinse:

PRECLEANING INSTRUCTIONS (OPTIONAL STEP): Although Sterilex Ultra Disinfectant Cleaner Solution 1 provides one-step cleaning and disinfection, precleaning may be desired for some surfaces in certain cases. 1) Prepare a precleaning solution by adding 3 - 6 fl. oz. of Sterilex Ultra DiSinfectant Cleaner Solution 1 and an equivalent amount of Sterilex Ultra Activator Solution to 1 gal. hot tap water in an appropriate plastic container, depending on the level of gross filth to be precleaned. 2) Clean surfaces with precleaning solution to by pouring, wiping, brushing, scrubbing, spraying with a coarse trigger sprayer, sponging, immersing, using a clean in place (CIP) system, pumping it through the system, drawing it through the system or mopping. 3) Before diSinfecting rinse all surfaces thoroughly with a potable water rinse.

DISINFECTION OF POULTRY HOUSE PREMISES, POULTRY HOUSE EQUIPMENT AND HATCHERIES

1) Remove all poultry and feeds from premises, trucks, coops, and crates. 2) Remove all litter and droppings from floors, walls and surfaces of facilities occupied or traversed by poultry .

. 3) Empty all troughs, racks, and other feeding and watering .appliances. . 4) Thoroughly clean all surfaces with soap or detergent and rinse with water or follow PRECLEANING INSTRUCTIONS below. 5) Saturate all surfaces with a solution prepared by adding 12.8 fl. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and 12.8 fl. oz. of Sterilex Ultra Activator Solution to 1 gal. tap water in an appropriate plastiC container and stirring. . 6) Thoroughly wet surfaces with use-solution by pouring, wiping. brushing. scrubbing. spraying with a coarse trigger sprayer, sponging, using a clean in place (CIP) system, pumping it through the system, drawing it through the system or mopping. The use-solution can be used to disinfect hatchers, setters, trays, racks, carts, sexing tables, delivery trucks and other hard surfaces in hatcheries. Immerse aU halters, ropes, and other types of equipment used in handling and restraining animals, as well as forks. shovels, and scrapers used for removing litter and manure. 7) Allow surfaces to remain wet for at le.ast 10 minutes. 8) Ventilate buildings, coops, and other closed spaces. Do not house poultry or employ equipment until treatment has been absorbed, set, or dried. 9) Thoroughly scrub treated feed racks, troughs, automatic feeders, fountains, and waterers with soap or detergent, and rinse with potable water before reuse.

APPLICATION INSTRUCTIONS FOR TRANSFER LINES: 1) Add 12.8 ft. oz. of Sterilex Ultra Disinfectant Cleaner Solution 1 and 12.8 fl. OZ, of Sterilex Ultra Activator Solution to 1 gal. tap. water in an appropriate plastic container and stir. . ACCEPl'ED 2) Introduce use solution into transfer lines and tanks for watering systems and nipple drinkers. inWtd:a~7Pt: 3) Soak or circulate use solution for at least 10 minutes. .' 4) Drain transfer lines and tanks. 5) Rinse all surfaces thoroughly with a potable water rinse. '. u~k,~ai~!

PRECLEANING INSTRUCTIONS (OPTIONAL STEP):. .' .. ~·:1!~(~: ... Although Sterilex Ultra Disinfectant Cleaner Solution 1 proVides one-step cleaning and dISIn=~t~~nl.ng., may be desired for some surfaces in certain cases. .":-"}-- -( ~i;j .' ; 1) Prepare a precleaning solution by adding 3 - 6 fl. oz. of Sterilex Ultra Disinfectant Cleaner SolUtl n '1 a~a an equivalent amount of Sterilex Ultra Activator Solution to 1 gal. hot tap water in an appropriate plastiC container, depending on the Jevel of gross filth to be precleaned. 2) Clean surfaces with precleaning solution to by pouring, wiping, brushing, scrubbing, spraying with a coarse trigger sprayer, sponging, immersing, using a clean in place (CIP) system, pumping it through the system, drawing it through the system or mopping. 3) Before disinfecting rinse all surfaces thoroughly with a potable water rinse.

Sterilex Ultra Disinfectant Cleaner Solution 1 (63761-8) .. ' . '.

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DISINFECTION INREf~IGERATED TRUCKS AND OTHERVEHICLES;II\jSTITUTIONS. INDUSTRIAL FACILITIES, SCHOOLS, ATHLETIC FACILITIES, REST ROOMS, HOTELS, MQTELS, OFFICE BUILDINGS AND OTHER PUBLIC AREAS, AND HOUSEHOLDS:

APPL'ICATION INSTRUCTIONS: 1) Add 12,8 fl. oz~ of SterllexUltra Disinfectant Cleaner Solution 1 and 12,8 fl. oz- of Sterilex Ultra Activator Solution to 1 gal. tap water inan appropriate plastic container and stir. 2) Thoroughly wet surfaces with use-solution ~y pouring, wiping, brushing. scrubbing. spraying with a coarse trigger spr~yer. sponging, using a clean in place (CIP) system j pumping it through the system,drawing itthrough the system or mopping. Clean all areas of veh.icles, including mats. crates, cabs and wheels. 3) Allow surfaces to remain wet.ror at least to minutes. 4). Rinse all surfaces thoroughly with a potabie water rinse.

PRECLEANING INSTRUQTIONS (OPTIOI'-:IAL STEP): . Although Ster'ilex Ultra DisinfectantCleaner Solutioi11 provides one-stepcleanirtgand,disinfectioil, precleaning may be desired for some surfaces in certain cases. 1) Prepare aprecleaning solution by adding 3 ·-Sf!. oz. of SterilexUltra DisinfectantCI~aner Solutioll1 and ail equivalent amounto(Sterilex Ultra,Activator Solution to 1 gal. hot tap water in an appropriate plastic container. depending On the level ofgross filth to be precleaned. . 2) Clean surfaces with precleaning solution to by pouring, wiping, brushing, ~crubbing, spraying with a coarse trigger sprayer,sponging, immersing. using a Clean in place (CIP) system, pumping it through the system, drawing it through the system orm.opping. 3) Before disinfecting rinse all surfaces thoroughly With a potable water rinse.

DISINFECTION OF SALON (BARBER) INSTRUMENTS AND TOOLS:

APPLICATION INSTRUCTIONS: 1)Add 12.8 fl. oz. of Sterilex Ultra Disinfec~nt Cleaner Solution 1 and 12.8J1.oz, of SterilexUltra Activator Solution t01 gal. tap water in an appropriate plastic container and stir. 2) Completely immerSe combs, brushes, rollers, manicure and other hard, nonporous salon instruments and tools for 10 minutes. . 3) Allow surfaces to remain wet for at least 10 minutes. 4) Rinse all thoroughly with potable water and dry before use. 5) Fresh solutiOhshould be prepared daily or more often if sol ution , becomes diluted or soiled.

NOTE: Plastics may remain iminers~duntil ready to use, Stainless steelshea~a.rldinstruments must be removed after 10 minutes, rinsed. dried and kept in a clean, nOI'l"Contaminated receptacle. Prolonged soaking may cause damage to metal instruments: .

PRECLEANING INSTRUCTIONS (OPTIONAL STEP}: Although Sterilex Ultra Disinfectant Cleaner S.olut/on1 provides one-step cleaning and disinfection, precleaning heavily soiled instruments and tools may be·desiredfor some surfaces in certain cases. . 1) Prepare a precleaning solution by adding 3 - 6 fl .. oz. of ~terilex Ultra Disinfectant Cleaner S.olution 1 and an ~uivalentamount 01Sterile)( Ultra Activator Solution to 1 gal, hot tap watei' in an appropriate plastic container. depending on the level of gross filth to be precleaned. . . . 2) Clean ~urfac~~with'precleaningsolution'to by pouring, w,iping. brushing, scrubbing. spraying with a coarse trigger sprayer; sponging or immersing. 3) Bef9re~isinfectjng rinse all surtacesthoroughly with. a potable water rinse.

Sterilex Ultra Disinfectant Cleaner Solution 1 (63761,.8)

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Sterilex Ultra Disinfectant Clean~r;~olutiori 1 (63761:.s)

ACCF.P'I'ED wiIh·~S

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Revised,March 1(, 20071 Page10.of 11

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SterilexUltra Disinfectant Cleaner Solution 1 (63761-8) Revised March 17. 20071 Page 11 of11