UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, DC 20460
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
July 21, 2016
Heather Bjornson-Lam
Regulatory Consultant
Veltek Associates, Inc.
15 Lee Boulevard
Malvern, PA 19335
Subject: Label Amendment – Adding Sterile Claim
Product Name: DECON-AHOL
EPA Registration Number: 68959-2
Application Date: March 22, 2016
Decision Number: 515725
Dear Ms. Bjornson-Lam:
The amended label referred to above, submitted in connection with registration under the Federal
Insecticide, Fungicide and Rodenticide Act, as amended, is acceptable. This approval does not
affect any conditions that were previously imposed on this registration. You continue to be
subject to existing conditions on your registration and any deadlines connected with them.
A stamped copy of your labeling is enclosed for your records. This labeling supersedes all
previously accepted labeling. You must submit one copy of the final printed labeling before you
release the product for shipment with the new labeling. In accordance with 40 CFR 152.130(c),
you may distribute or sell this product under the previously approved labeling for 18 months
from the date of this letter. After 18 months, you may only distribute or sell this product if it
bears this new revised labeling or subsequently approved labeling. “To distribute or sell” is
defined under FIFRA section 2(gg) and its implementing regulation at 40 CFR 152.3.
Should you wish to add/retain a reference to the company’s website on your label, then please be
aware that the website becomes labeling under the Federal Insecticide Fungicide and Rodenticide
Act and is subject to review by the Agency. If the website is false or misleading, the product
would be misbranded and unlawful to sell or distribute under FIFRA section 12(a)(1)(E). 40
CFR 156.10(a)(5) list examples of statements EPA may consider false or misleading. In addition,
regardless of whether a website is referenced on your product’s label, claims made on the
website may not substantially differ from those claims approved through the registration process.
Therefore, should the Agency find or if it is brought to our attention that a website contains false
or misleading statements or claims substantially differing from the EPA approved registration,
the website will be referred to the EPA’s Office of Enforcement and Compliance.
Your release for shipment of the product constitutes acceptance of these conditions. If these
conditions are not complied with, the registration will be subject to cancellation in accordance
FQPA Label Acceptable v.20150320
Page 2 of 2
EPA Reg. No. 68959-2
Decision No. 515725
with FIFRA section 6. If you have any questions, please contact Terria Northern by phone at
703-347-0265, or via email at [Link]@[Link].
Sincerely,
Julie Chao, Product Manager 33
Regulatory Management Branch 1
Antimicrobials Division (7510P)
Office of Pesticide Programs
Enclosure: Approved label
IMPORTANT NOTICE
This product is registered in both the U.S. and Canada
It has BOTH U.S. and Canadian Labeling
WHEN USING THIS product in the U.S. follow the U.S. information, where indicated
WHEN USING THIS product in Canada, follow the Canadian information, where indicated
DECON-AHOL®mc
WFI Formula
[Gamma Irradiated] [Sterile]
For Use in Clean Rooms and Controlled Areas
Hard Surface Disinfectant
Active Ingredient:
Isopropyl Alcohol CAS# 67-63-0 ................ 70.0%
Other Ingredients:
*Water …………………………………………30.0%
Total:………………………………………… 100.0%
*USP Water for Injection
KEEP OUT OF REACH OF CHILDREN
DANGER
FLAMMABLE
Keep away from heat or open flame.
Store at room temperature below 48.8°C (120°F)
(Note to reviewer: The following reference statements available for various packaging scenarios.)
See [side] [other] [back] [case label] [panel] [and/or] [package insert] for [first aid] [precautionary
statements] [directions for use] [additional precautions] [and] additional product information].
[Refer to the primary case label for [additional] precautionary statements, directions for use, and
additional product information]
[Peel [here] [back] for [Spanish and] additional information]
[See container for lot number and storage expiration date]
US EPA Reg. No.: 68959-2
US EPA Est. No.: 68959-PA-001
Canadian DIN: 02351374
Manufactured by:
Veltek Associates, Inc. Jul 21, 2016
15 Lee Blvd.
Malvern, PA 19355-1234
Inquiries: (888) 478-3745
68959-2
In Canada: Distributed by:
Canada Clean Room
280 Terance Mathews
Kanata, On. K2M 2C6
Veltek Associates – DECON-AHOL (EPA Reg. No. 68959-2)
NAFTA Label fast-track amendment version (7) dated March 17, 2016
Page 1 of 4
Inquiries: (888) 595-8070
Net Contents: (In Canada XXXX mL or litres) (In US XXX oz or gallons)
FIRST AID
If in eyes x If splashed in eyes, hold eye open and rinse slowly and gently with
water for 15-20 minutes.
x Remove contact lenses, if present, after the first five minutes, then
continue rinsing eye.
x Call a poison control center or doctor for treatment advice.
If swallowed x Call a poison control center or doctor immediately for treatment
advice.
x Have person sip a glass of water if able to swallow.
x Move person to fresh air.
x Do not induce vomiting unless told to by a poison control center or
x Doctor.
x Do not give anything to an unconscious person.
x Have product container or label with you when calling poison control or
doctor, or going for treatment.
If inhaled x Move person to fresh air.
x If person is not breathing, call 911 or an ambulance, them give artificial
respiration, preferably mouth-to-mouth if possible.
x Call poison control center or doctor for treatment advice.
If on skin or x Take off contaminated clothing.
clothing x Rinse skin immediately with plenty of water for 15 – 20 minutes.
x Call a poison control center or doctor for treatment advice.
EMERGENCIES: For Spill/Exposure/Poison Control Emergency Response Service [from the
USA and Canada in English, French and Spanish (and 23 other languages)] call
CARECHEM24 toll free at 866-928-0789.
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
DANGER: Causes irreversible eye damage. Harmful if swallowed of inhaled. Do not get in eyes or on
clothing. Avoid breathing vapor or spray mist. Avoid contact with skin or clothing. Wear protective
eyewear such as goggles of face shield, protective clothing and chemically resistant gloves. Wash
thoroughly with soap and water after handling, before eating, drinking, chewing gum or using tobacco or
using the toilet. Remove and wash contaminated clothing before reuse. Prolonged or frequently repeated
skin contact may cause allergic reactions in some individuals.
This product may be irritating to the eyes, skin, gastrointestinal tract and respiratory system. May cause
central nervous system depression.
PHYSICAL AND CHEMICAL HAZARDS: Flammable liquid and vapor. Keep away from heat or open
flame. Exposure to temperatures above 48.8°C (120˚ F) may cause bursting. Do not mix this product
with other chemicals including: acids, oxidizing materials, combustible materials, halogens, peroxides,
bases and metal salts.
Veltek Associates – DECON-AHOL (EPA Reg. No. 68959-2)
NAFTA Label fast-track amendment version (7) dated March 17, 2016
Page 2 of 4
DIRECTIONS FOR USE
Read the label before using
In the United States: It is a violation of Federal law to use this product in a manner inconsistent with its
labeling.
In Canada: This product is to be used only in accordance with the directions on the label. It is an offence
to use this product in a way that is inconsistent with the directions on the label.
This product 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. This product may be used to pre-clean or decontaminate critical or semi-critical medical devices prior to sterilization
or high-level disinfection.
USE: Disinfects and sanitizes clean rooms and controlled areas such as those used in healthcare
institutions, biopharmaceutical, pharmaceutical, medical device and diagnostic manufacturing facilities.
Use on hard non-porous inanimate surfaces in aseptic filling and gowning rooms, general manufacturing
areas, or on machinery, tables, counters, laminar flow benches, floors, walls, carts, shelves made of
hard non-porous materials, such as, glass, plastic, vinyl, chrome, and stainless steel. It is compatible
with most hard surface materials.
DISINFECTION: Use this product while wearing personal protection. Wear protective eyewear such as
goggles of face shield, protective clothing and chemically resistant gloves. Use with adequate ventilation
and spray away from eyes and face. DECON-AHOL is ready to use. Do not dilute. Pre-clean surface or
item of heavy soil or gross filth before application. Hold can upright 6-8 inches from surface. Thoroughly
wet surface with DECON-AHOL and allow to remain wet for a minimum of 10 minutes. Allow surface to air
dry, or after 10 minutes wipe dry with sterilized cloth, wiper, if needed.
DECON-AHOL is bactericidal. The results of AOAC Efficacy Tests show that DECON-AHOL is an effective
hard surface disinfectant against Pseudomonas aeruginosa (ATCC# 15442), Staphylococcus aureus
(ATCC#6538), and Salmonella enterica (ATCC#10708) in the presence of fetal bovine serum organic
load in 10 minutes.
SANITIZATION: Use 5 minute contact time on hard, non-porous surfaces (made from: stainless steel,
glass, Corian™, laminate flooring, aluminum, pvc, mild steel, polypropylene), in isolators, clean rooms,
sterile and controlled areas, gowning rooms and on process lines, gloves, work surfaces, tools and
equipment.
DECON-AHOL is an effective sanitizer on inanimate, non-food contact surfaces against Staphylococcus
aureus (ATCC#6538) and Klebsiella pneumoniae (ATCC#4352) in the presence of fetal bovine serum
organic load in 5 minutes.
Veltek Associates – DECON-AHOL (EPA Reg. No. 68959-2)
NAFTA Label fast-track amendment version (7) dated March 17, 2016
Page 3 of 4
Storage and Disposal
Do not contaminate water, food, or feed by storage or disposal.
Storage: Store in the original container in a dry cool place below 48.8°C (120˚ F). Absorb spills
with inert dry absorbent or sand. Absorb spills with inert material (e.g., dry sand or earth), then
place in a chemical waste container.
Disposal: Product and product wastes are toxic. Follow Federal/Provincial/State regulations and
Local/Municipal ordinances when disposing of this product. Improper disposal of excess product,
spray mixture or rinsate is a violation of Federal/Provincial/State Laws. If these wastes cannot be
disposed of by use according to label instructions, contact your Federal/Provincial/State or
Local/Municipal environmental control agency for guidance. Contaminated absorbent in drums
must be disposed of via an authorized waste disposal contractor. Never place unused product
down any indoor or outdoor drain.
Container Disposal: Non-refillable container. Do not reuse this container to hold materials other
than pesticides or diluted pesticides (rinsate). Triple rinse container promptly after emptying.
Triple rinse as follows: [(for containers less than 5 gallons) Fill container ¼ full with water and
recap. Shake 10 seconds. Follow Pesticide disposal instructions for rinsate disposal. Drain for 10
seconds after flow begins to drip. Repeat two more times.][(for containers greater than 5 gallons)
Fill container ¼ full with water. Tip container on its side and roll it back and forth, ensuring one
complete revolution for 30 seconds. Stand the container on its end and tip it back and forth several
times. Turn the container on its other end and tip it back and forth several times. Follow Pesticide
disposal instructions for rinsate disposal. Drain for 10 seconds after flow begins to drip. Repeat two
more times. ] Offer for recycling where available or puncture and dispose of in a sanitary landfill, or
by other procedures approved by state and local authorities.
Lot number/ Batch Code: XXXXX
EXPIRY: day/MONTH/year. Once opened use within (90 Days)
[MSDS] [No.]: XXXXX [Label No. XXXXX] [Reorder #]: XXXXX [Rev XX/XX]
[US Patent 6,123,900, 6,333,006, 6,607,695] [Made in USA]
Veltek Associates – DECON-AHOL (EPA Reg. No. 68959-2)
NAFTA Label fast-track amendment version (7) dated March 17, 2016
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