It is a violation of Federal Law to use N601+ in a manner inconsistent with its labeling.
N601+ is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.
N601+ may be used to pre-clean or decontaminate critical or semi-critical medical devices prior to sterilization or high level disinfection. Before use in federally inspected meat and poultry food processing plants, food products and packaging materials must be removed from room or carefully protected.
A potable water rinse is not allowed following use of N601+ as a sanitizer on previously cleaned hard surfaces provided that the surfaces are adequately drained before contact with food so that little or no residue remains.
Apply N601+ with a cloth, mop or mechanical spray device. When applied with a mechanical spray device, surfaces must be sprayed until thoroughly wetted. Treated surfaces must remain wet for 10 minutes. For sprayer applications, use a mechanical spray device or trigger spray device. Spray 6-8 inches from surface, rub with brush, sponge or cloth. Do not breathe spray.
NOTE: With spray applications, cover or remove all food products. A fresh solution should be prepared at least daily or when use solution becomes visibly dirty. For heavily soiled areas, a preliminary cleaning is required.
Hospitals, Dental Offices, Nursing Homes and other Health Care Institutions.
For disinfecting floors, walls, countertops, bathing areas, lavatories, tables, chairs, garbage pails and other hard non-porous surfaces: Add 4 ounces of N601+ to 5 gallons of water (625 ppm active quat). Treated surfaces must remain wet for 10 minutes.
At this use level, N601+ is bactericidal according to the AOAC Use Dilution Test method on hard inanimate surfaces modified in the presence of 5% organic serum against: Burkholderia cepacia, Pseudomonas aeruginosa, Campylobacter jejuni, Corynebacterium ammoniagenes, Salmonella typhi, Escherichia coli 0157:H7, Shigella sonnei, Enterococcus faecium Vancomycin Resistant, Staphylococcus aureus, Klebsiella pneumoniae, Staphylococcus aureus Methicillin resistant, Listeria monocytogenes, Proteus mirabilis, Yersinia enterocolitica.
At 4 ounces per 5 gallons use level (625 ppm active quat), N601+ was evaluated in the presence of 5% serum with a 10 minute contact time and found to be effective against the following viruses on hard nonporous environmental surfaces. Avian influenza /Turkey/Wisconsin, Influenza A2/Japan, Infectious Bronchitis Virus, Herpes Simplex Type1, Herpes Simplex Type 2, Vaccinia virus, Hepatitis B Virus.
Disinfection in Non-Medical Facilities (schools, restaurants, food services, farm, beverage and food processing plants): Add 4 ounces of N601+ to 5 gallons of water (469 ppm active quat).
At this use level, N601+ is bactericidal according to the AOAC Use Dilution Test method on hard inanimate surfaces modified in the presence of 5% organic serum with a 10- minute contact time against: Campylobacter jejuni, Escherichia coli 0157:H7, Staphylococcus aureus, Listeria monocytogenes, Staphylococcus aureus (Methicillin resistant), Proteus mirabilis, Yersinia enterocolitica.
*KILLS HIV AND HBV ON PRECLEANED ENVIRONMENTAL SURFACES/OBJECTS PREVIOUSLY SOILED WITH BLOOD/BODY FLUIDS in health care setting or other settings in which there is an expected likelihood of soiling of inanimate surfaces/objects with body fluids and in which the surfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for transmission of human immunodeficiency virus Type I (HIV-1) (associated with AIDS).
SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATION AGAINST HIV-1 AND HBV ON SURFACES/OBJECTS SOILED WITH BLOOD/BODY FLUIDS.
Personal Protection: Specific barrier protection items to be used when handling items soiled with blood or body fluids are disposable latex gloves, gowns, masks, or eye coverings.
Cleaning Procedure: Blood and other body fluids must be thoroughly cleaned from surfaces and objects before application of the disinfectant.
Disposal of Infectious Materials: Blood and other body fluids should be autoclaved and disposed of according to federal, state and local regulations for infectious waste disposal.
Contact Time: Leave surfaces wet for two minutes with 4 ounces per 5 gallons (or equivalent use dilution) (625 ppm active quat) use solution. This contact time will not control other common types of viruses and bacteria. For HBV, leave surfaces wet for 10 minutes with 4 ounces per 5 gallons (or equivalent use dilution) (625 ppm active quat) in the presence of 200 ppm hard water (CaCO3 and 100% serum). Efficacy tests have demonstrated that N601+ is an effective bactericide, virucide and fungicide in the presence of organic soil (5% blood serum).
Fungicidal Activity: At 4 ounces per 5 gallons use-level, (or equivalent use dilution) (625 ppm active quat) N601+ is effective against Trichophyton mentagrophytes (athlete’s foot fungus) on inanimate surfaces in the presence of 5% blood serum.
Mold and Mildew Control: At 4 ounces per 5 gallons, (or equivalent use dilution) (625 ppm active quat) N601+ will effectively inhibit the growth of mold and mildew and the odors caused by them when applied to hard non-porous surfaces (as indicated in general instructions above). Allow to dry on surface and repeat treatment every seven days or when new growth appears.
To disinfect food service establishment food contact surfaces: countertops, appliances, tables add 4 ounces of N601+ to 5 gallons of water (or equivalent use dilution) (625 ppm active quat). Before using N601+, food products and packaging materials must be removed from area or carefully protected. For heavily soiled areas, a pre-cleaning step is required. Apply solution with a mop, cloth, sponge, auto scrubber, mechanical spray device or by immersion so as to wet all surfaces thoroughly. For sprayer applications, spray 6-8 inches from surface. Allow to remain wet for 10 minutes, then remove excess liquid and rinse the surface with potable water.
FOOD CONTACT SANITIZING DIRECTIONS
Before use as a sanitizer in public eating places, food products and packaging materials must be removed from the room or carefully protected. Prior to application, remove gross food particles and soil by a pre-flush or pre-scrape and when necessary, presoak. Then thoroughly wash or flush objects with a good detergent or compatible cleaner, followed by a potable water rinse before application of the sanitizing solution.
FOOD CONTACT SANITIZING PERFORMANCE: At 1 ounce per 4 gallons of water (200 ppm active), this product eliminates 99.999% of the following bacteria in 60 seconds in 500 ppm hard water (calculated as CaCO3) according to the Germicidal and Detergent Sanitizing Action of Disinfectants test: Aeromonas hydrophila, Clostridium perfringens, Escherichia coli, Enterobacter sakazakii, Salmonella typhi, Streptococcus pyogenes, Campylobacter jejuni, Escherichia coli 0157:H7, Escherichia coli 0111:H8, Shigella dysenteriae, Yersinia enterocolitica, Listeria monocytogenes, Staphylococcus aureus, Enterococcus faecalis Vancomycin resistant.
SANITIZING OF FOOD PROCESSING EQUIPMENT, ICE MACHINES AND OTHER HARD NON-POROUS SURFACES IN FOOD CONTACT LOCATIONS, RESTAURANTS AND BARS DIRECTIONS: For sanitizing food processing equipment, refrigerated storage and display equipment and other hard, non-porous surfaces. Food contact surfaces must be thoroughly pre-flushed or pre-scraped and, when necessary, presoaked to remove gross food particles.
1. Turn off refrigeration (Note: Use this direction only if applicable).
2. Unit must be washed with a compatible detergent and rinsed with potable water before sanitizing. (Note: Use this direction only if applicable).
3. Wash and rinse all surfaces thoroughly.
4. Apply a solution of 1-2 ounces of this product per 4 gallons of water (or equivalent use dilution) (200-400 ppm active) by mechanical spray device, coarse pump or trigger spray device, direct pouring or by recirculating through the system.
5. Surfaces must remain wet for at least 60 seconds followed by complete draining.
6. Allow surfaces to air dry.
7. NO POTABLE WATER RINSE IS ALLOWED after use as a sanitizer.
8. Fresh solution must be used for each cleaning.
9. Return machine to service.