UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: March 11 , 20 14 

SUBJECT: Metofluthrin: Review of Human Incidents for Preliminary Risk Assessment 

PC Code: I 09709 DP Barcode: 0418298 

Decision No.: 488164 

Petition No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXR No.: NA CAS No.: 240494-70-6 

MRID No.: NA 40CFR: NA 

FROM: Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

and 

Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Ver.Apr.08 

THROUGH: David J. Miller, Acting Branch Chief li ,. / Y/t{ ~ /d/hcJI' • ~i}l '/ 

Toxicology and Epidemiology Branch Jz~; _, 'f.t 

Health Effects Division (7509P) 

TO: Linnea Hansen, Risk Assessor 

Risk Assessment Branch II 

Health Effects Division (7509P) 

and 

Veronica Dutch, Chemical Review Manager 

Risk Management & Implementation Branch V 

Pesticide Re-evaluation Division (7508P) 

Page 1 of 19 
Summary and Conclusions 

Metofluthrin was previously reviewed in 2012 (S. Recore, 09/06/2012, 0404998). It was 

concluded that "overall the incident cases reported for metofluthrin were generally low 

frequency and low severity of incident." However because Registration No. 4822-542 (OFF! 

Clip-On Mosquito Repellent) was a relatively new delivery method and there were 39 moderate 

incidents reported in Main IDS, HED concluded that these incident data may warrant further 

analysis in the preliminary risk assessment phase of Registration Review. 

There were 14 additional moderate incidents and one major incident reported to IDS since the 

previous review. In addition, four low severity cases reported to SENSOR-Pesticides were 

reviewed. This updated review concurs with the previous conclusion. Overall the incident cases 

reported for metofluthrin were generally of low frequency and low severity in both IDS and 

NIOSH SENSOR-Pesticides. There does not appear to be a concern at this time that would 

warrant further investigation. The Agency will continue to monitor the incident information and 

if a concern is triggered, additional analysis will be conducted. 

Detailed Review 

I. ACTION REQUESTED 

Metofluthrin is a pesticide being considered under the FQPA-mandated Registration Review 

program established to review, on a 15 year cycle, pesticides for which a Re-registration 

Eligibility Decision has been made. One component of the Agency's Registration Review 

Program is consideration of human incident data. In conjunction with a human health risk 

assessment based on other data sources, such human incident data can assist the Agency in better 

defining and characterizing the risk of pesticides/pesticide products. 

Metofluthrin was previously reviewed in 2012 (S. Recore, 09/06/2012, 0404998). It was 

concluded that because Registration No. 4822-542 (OFF! Clip-On Mosquito Repellent) was a 

relatively new delivery method and there were 39 moderate incidents reported in Main IDS, 

these incident data may warrant further analysis in the preliminary risk assessment phase of 

Registration Review. 

Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an 

"incident") are largely self-reported and therefore, generally speaking, neither exposure to a 

pesticide or reported symptom (or the connection between the two) is validated or otherwise 

confirmed. Typically, causation cannot be determined based on incident data. However, 

incident information can be an important source of feedback to the Agency: incidents of severe 

outcome, or a suggested pattern or trend among less severe incidents, can signal the Agency to 

further investigate a particular chemical or product. Observational epidemiology studies relate 

the risk of disease, e.g., cancer, and exposure to an agent such as a pesticide product in the 

general population or specific sub-groups like pesticide applicators. 

Page 2 of 19 
Page 3 of 19

II. BACKGROUND

Metofluthrin is a Type 1 pyrethroid active ingredient used to control insects. The product of 

concern in this review is a personal outdoor insect repellent product consisting of a holder 

attached to the individual’s clothing (such as a belt). The holder contains a replaceable cartridge 

insert coated with up to 50 mg of metofluthrin. The product is activated by turning on a battery 

powered fan to release the metofluthrin into the air surrounding the individual. 

For this evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control 

and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel 

Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient metofluthrin (PC Code: 109709). 

The purpose of the database search is to identify potential patterns in the frequency and severity 

of the health effects attributed to metofluthrin exposure. 

III. RESULTS/DISCUSSION

a. IDS (Incident Data System)

OPP’s IDS includes reports of alleged human health incidents from various sources, including 

mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports 

from registrants, other federal and state health and environmental agencies, and individual 

consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from 

across the U.S. and most incidents have all relevant product information recorded. Reports 

submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in 

the report. 

IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

 

o Main IDS contains incidents resulting in higher severity outcomes and provides 

more detail with regard to case specific. This system stores incident data for 

death, major and moderate incidents, and it includes information about the 

location, date and nature of the incident. Main IDS incidents involving only one 

pesticide are considered to provide more certain information about the potential 

effects of exposure from the pesticide. 

o Aggregate IDS contains incidents resulting in less severe human incidents (minor, 

unknown, or no effects outcomes). These are reported by registrants only as 

counts in what are aggregate summaries. 

For the Main IDS, from January 1, 2007 to January 7, 2014, there were 54 incidents reported for 

single chemical only in the database involving metofluthrin.1 One incident was classified as 

major severity and 53 incidents were classified as moderate severity. The incident narratives are 

summarized in Appendix 1. In Aggregate IDS, from January 1, 2007 to January 7, 2014, there 

 

1 There were also four additional incidents reported that occurred in Canada. Foreign incidents are not reviewed in 

detail because of the potential differences in the exposure patterns, use practices, and product formulation.
Page 4 of 19

were 5 reported incidents involving metofluthrin. These incidents were classified as minor 

severity.

The number of incidents reported over time to IDS are listed in Table 1. There are 

approximately 12 incidents reported per year for metofluthrin to the IDS databases. 

Table 1. Incidents Reported to Main and Aggregate 

IDS Over Time 2009-2013*

Year Number of Incidents

2009 10

2010 13

2011 17

2012 10

2013 9

* Although the query did included years 2007 and 2008, no 

incidents were reported for metofluthrin before 2009.

The only product implicated in the incidents was Registration No. 4822-542 (OFF! Clip-On 

Mosquito Repellent). This product is a personal outdoor insect repellent product consisting of a 

holder attached to the individual’s clothing (such as a belt). 

Six of these incidents appeared to be due at allergic reactions to the products. Eleven of the 

incidents appeared to be due to potential misuse. Of these 11 incidents, five cases reported that 

the individual wore the product clipped to their shirt (up around their face), three cases 

reportedly used the product indoors, and three case reported direct contact with the active 

ingredient. The other 43 cases appeared to use the product according to the label directions, 

either clipping the product to their belts or setting it on a table beside them.

Based on the IDS reports, dermal symptoms were reported most often (n=31) by the exposed 

individuals. Other symptoms reported included neurological (n=15), respiratory (n=10),

gastrointestinal (n=4), ocular (n=4), and cardiovascular (n=3). Note that a patient could exhibit 

multiple symptoms. Dermal symptoms reported include hives, itchiness, rash, blisters, welts, 

swelling, redness and skin irritation. Neurological symptoms reported include weakness, 

headache, lightheadedness, fainting, and memory lost. Respiratory symptoms reported included 

coughing, asthma, throat irritation, bronchitis, and shortness of breath. Ocular symptoms 

reported were redness, irritation, cloudy vision, and ocular discharge. Gastrointestinal symptoms 

reported were nausea, diarrhea, and vomiting. Cardiovascular symptoms reported include low 

chest pain, heart palpitations, and heart attack.
Page 5 of 19

b. SENSOR-Pesticides

The SENSOR-Pesticides database covers 11 states from 1998-2009, although reporting varies 

from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, 

including: reports from local Poison Control Centers, state Department of Labor workers’ 

compensation claims when reported by physicians, reports from State Departments of 

Agriculture, and physician reports to state Departments of Health. Although both occupational 

and non-occupational incidents are included in the database, SENSOR focuses on occupational 

pesticide incidents, and is of particular value in providing that information. A state SENSOR 

contact specialist attempts to follow-up with cases and obtains medical records to verify 

symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized 

protocol and case definitions derived from poison center reporting, SENSOR coordinators at 

State Departments of Health enter the incident interview description provided by the case, 

medical report, physician and patient into the SENSOR data system. The SENSOR data system 

is accessible to participating states and EPA.

A query of SENSOR-Pesticides from 1998-2010 identifies 4 single ai cases, stemming from 3 

events, involving metofluthrin (pc code 109709). No multiple ai cases were found. These four 

cases were not work-related. All four cases were low in severity. All cases were reported in 

2010. Two of the cases involved children. Three cases involved the product OFF! Clip-On 

Mosquito Repellent, EPA Reg # 4822-542 and case one involved OFF! Hangables, EPA Reg # 

10308-31. One case experienced respiratory symptoms. One case experienced ocular 

symptoms. Three cases reported nervous system symptoms including headache. Two cases had 

gastrointestinal symptoms including vomiting. The cases are described in Table 2.

Table 2. SENSOR-Pesticides 1998-2010 

Metofluthrin Case Reports

N=4

Case ID Case Description

FL03883 Caller states that his six year old son rubbed his eyes with off 

clip on which he had in his grand parents' house.

MI02241 Used product, developed symptoms

MI02242 Product was clipped to pants for 2 days. On the second day the 

[5 year-old] case developed symptoms

NC02713 Woman was exposed to clip on mosquito repellent and had 

symptoms
Page 6 of 19

IV. CONCLUSION

Metofluthrin was previously reviewed in 2012 (S. Recore, 09/06/2012, D404998). It was 

concluded that “overall the incident cases reported for metofluthrin were generally low 

frequency and low severity of incident.” However because Registration No. 4822-542 (OFF! 

Clip-On Mosquito Repellent) “is a relatively new delivery method and there were 39 moderate 

incidents reported in IDS Main, these incident data may warrant further analysis in the 

preliminary risk assessment phase of Registration Review.” 

There were 14 additional moderate incidents and one major incident reported to IDS since the 

previous review. In addition, four low severity cases reported to SENSOR-Pesticides were 

reviewed. This updated review concurs with the previous conclusion. Overall the incident cases 

reported for metofluthrin were generally of low frequency and low severity in both IDS and 

NIOSH SENSOR-Pesticides. There does not appear to be a concern at this time that would 

warrant further investigation. The Agency will continue to monitor the incident information and 

if a concern is triggered, additional analysis will be conducted.
Page 7 of 19

Appendix 1. Incident Narratives

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

Chemical: Metofluthrin PC Code: 109709

Incident 

Package 

Report

Incident 

Date Location Country

Exposure 

Severity Incident Description

020923 -

00020 6/19/2009 RICHMOND, TX US MODERATE

A 63 year old female used the product as directed 1-2x within the past 2-3 

weeks, the last time being about 2-3 days ago. Last week she developed 

symptoms of red blotches and dryness on her face and arms. She has been 

to a dermatologist and was given a topical steroid. Her MD was unable to 

determine the cause of the symptoms. 

021075 -

00010 1/1/2009

SAN ANTONIO, 

TX US MODERATE

Caller states she is involved in the LTC care of a quadriplegic (72 year old

male) that has had the product in his room with a fan circulating the air for 

approx the last 48 hours. Caller states that 24 hrs ago he was noted to 

have blood glucose of 25 mg/dL. He was given one amp of dextrose and 

blood sugar increased to 173 mg/dL but then started to fall again and within 

one hr fell back to approx 25 mg/dL and another amp of dextrose was given 

with same results as previous. He is being evaluated by a physician now 

and the physician has been unable to determine the cause.

021075 -

00018 6/30/2009 COOKVILLE, TN US MODERATE

A 53 year old female has been using the product over the past 3 weeks on a 

daily basis, and is noting a loss of memory over the past 3 weeks. She is 

making mistakes and not realizing them. During use she clips the product to 

her belt and removes it when protection is no longer needed.

021075 -

00027 7/25/2009 EL PASO, TX US MODERATE

Caller state that her mother-in-law (63 year old) fell down while wearing the

product. She was on the floor for an unknown period of time. 24 hours later 

she was feeling 'chest pains, cannot swallow or talk'. 

021075 -

00030 1/1/2009 CANTON, TX US MODERATE

A 52 year old female used product 5 wks ago. Over the 1 week that the 

product was used, caller clipped it on her belt and on the collar of her shirt. 

1 wk after use she complained of coughing, weakness, hoarseness and 

'feels like it is difficult to get oxygen'. Has not used product since and 

symptoms have persisted for the past 3 wks.

021187 -

00003 1/1/2009

PASO ROBLES, 

CA US MODERATE

An 85 year old female began using the product daily about I month ago, with 

her most recent use yesterday. About 3 weeks ago, she began to 

experience asthma attack that has worsened since. 3 days ago she was 

seen by MD, who prescribed prednisone pills. Symptoms have improved 

with this regimen.

021187 - 1/1/2009 WRIGHTSTOWN, US MODERATE Caller states that her 64 year old sister has been regularly using the product 
Page 8 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

Chemical: Metofluthrin PC Code: 109709

Incident 

Package 

Report

Incident 

Date Location Country

Exposure 

Severity Incident Description

00010 NJ for about the past month. For about the past 2 weeks, sister began to wear 

the product about her neck when using it. At about this time, she developed 

cough and throat irritation. Over the past several days, she has had a 

diminished voice and bloody saliva. She did not read label directions until 

after use, and is being seen by MD today. She went to the MD and was 

diagnosed with pneumonia. Caller stated that the MD determined that the 

product wasn't likely the cause of the symptoms but could had exasperated 

them Caller stated that her sister has been taking antibiotics and is 

beginning to feel better.

021187 -

00017 1/1/2009

PORTSMOUTH, 

NH US MODERATE

A 61 year old female used the product 3 weeks ago, and wore it daily for 1 

week; she discontinued use 2 weeks ago. She began to experience hair 

loss and lethargy about 2 weeks ago, prompting her to discontinue use of 

product. Caller went to MD due to symptoms, and had low RBCs on blood 

work, but MD did not feel it was of clinical significance. 

021299 -

00001 1/1/2009 GROVES, TX US MODERATE

An 83 year old female placed the product on her t-shirt, near her waist on 

Thursday and Friday. On Friday within 8 hours after beginning the use of 

the product, she developed symptoms of a rash, itching and hives/welts on 

her neck, under her chin. She had the product facing away from her skin. 

She took oral Benadryl to help relieve the symptoms with no relief. 

Yesterday she got two topical meds from her MD, Betamethasone and 

Eramosone 1% and that she began applying the meds last night and the 

symptoms are beginning to improve.

021299 -

00026 9/19/2009

PRAIRIE 

VILLAGE, KS US MODERATE

A 77 year old female wore the product on her belt outside 4 days ago and 

4-5 hours later broke out into hives over her whole body. 7-8 hours after 

using the product, her throat began swelling and she experienced an 

episode of syncope. She had swelling of the ears and throat and swelling of 

both of her hands. The next day her hands were still swollen and over the 

next 24 hours the hand swelling improved. 

022109 -

00010 6/1/2010 PERU, NY US MODERATE

A 7 year old male used the product while camping 1week ago. Within 

several days of the first use the child became pruritic and developed a full 

body rash. The child was taken to the MD yesterday as well as the day 

before and the child was prescribed Benadryl as well as a Cortisone 

Ointment. The MD was unsure what caused the rash.
Page 9 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

Chemical: Metofluthrin PC Code: 109709

Incident 

Package 

Report

Incident 

Date Location Country

Exposure 

Severity Incident Description

022109 -

00013 6/4/2010 DETROIT, MI US MODERATE

Caller used the product on herself. She developed a headache and cough 

about 4 hours later. Headache persisted through yesterday. Cough currently 

persists. She was seen at urgent care clinic yesterday and diagnosed with 

bronchitis. MD prescribed antibiotics. 

022109 -

00014 6/5/2010 DETROIT, MI US MODERATE

The product was clipped onto the pants of a 4 year old male grandson while 

he was outside. That evening, child began to complain of headache and 

vomited. Child developed temperature of 102 and is currently at urgent care 

clinic.

022109 -

00016 6/6/2010

FAIRFAX 

STATION, VA US MODERATE

A 56 year old female used the product. She experienced rash with welts and 

pruritis. She was unsure if rash was from product or poison ivy.

022109 -

00029 6/21/2010

SAN ANTONIO, 

TX US MODERATE

A 9 year old female used the product on her right side today for about 20 

minutes. Then set it down on a table near her. She c/o itching and when she 

got home she has a raised rash on her right side, hip and back. She's been 

bathed in an oatmeal bath and given Benadryl. Her pediatrician has been 

called. On call back, her rash and welts were subsiding and she is 

improving.

022109 -

00033 6/15/2010 PATERSON, NJ US MODERATE

A 56 year old male used the product two weeks ago. He developed a 

neurological illness with visual disturbances such as double vision, 

inflammation of the

ocular nerve, and a spike in BP resulting in hospitalization. Since there is no 

obvious cause, caller is researching several products he used about the 

time he got sick. He used tile product according to package instructions, and 

discontinued use of the product because he was in the hospital. MD was 

unable to determine cause of caller's symptoms. MD is treating caller with 

unknown medications. Symptoms have resolved with treatment.

022224 -

00009 6/23/2010 DANVILLE, VA US MODERATE

A 73 year old male states that he used the product for about 2 weeks. Caller 

states that at times he clipped the product to his chair. He said it’s possible 

that the product got onto his skin. He noticed a rash on the upper parts of 

both arms and thighs 1 week after using product. He discontinued using the 

product after about 2 weeks. The rash had not improved even after two 

days of discontinued use. Caller saw MD for evaluation that was unsure of 

the cause of symptoms. MD gave a steroid injection, and symptoms cleared 

within a few days of treatment.
Page 10 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

Chemical: Metofluthrin PC Code: 109709

Incident 

Package 

Report

Incident 

Date Location Country

Exposure 

Severity Incident Description

022224 -

00010 6/24/2010 WHIPPANY, NJ US MODERATE

An adult male reports that he has been using the product for the last two 

weeks. He developed a rash sometime in that two week period of using the 

product per label directions. The rash has developed on his shins, back and 

arms. He saw MD for evaluation who suspected allergic reaction to 

something. MD prescribed

prednisone, and symptoms have almost completely resolved.

022224 -

00012 7/9/2010 BOSQUE, NM US MODERATE

A 54 year old female used the product and may have breathed some of it in. 

She woke up the next morning and her face was swollen, red, and irritated. 

Caller went to MD and was prescribed Prednisone. Symptoms have 

improved. MD said that site had an allergic reaction to an ingredient in the 

product. 

022224 -

00013 7/2/2010 DAYTON, OH US MODERATE

A 72 year old male used the product. He used it for about 2 hrs on the first 

day and about 1 hour on the second day. By that evening he was exhibiting 

a few welts, and used Benadryl cream for the itching. By the next morning, 

he was covered in welts and especially around the area where the clip-on 

was attached to his belt. He had taken a bath the night before and put on 

cream all night. He was taken to the hospital and given a shot for the welts 

and 3 prescriptions to calm the itching and take the welts down.

022224 -

00018 7/4/2010

HAUPPAUGE, 

NY US MODERATE

A 78 year old female used product at a barbecue. She did not touch the 

product other than to set it up with her hands. Unsure if she washed her 

hands after touching product. She developed red marks that looked like 

hives on 'different parts of her body' 8 hours after use. The following day 

she had more hives, so she

sprayed her bed with insecticide in case she had a bug in her bed. She 

consulted an MD 2 days after symptoms started. The MD kept her 

overnight in the hospital and gave her steroids. She was sent home with 

Prednisone. 

022298 -

00030 8/23/2010 LAKESIDE, AZ US MODERATE

An adult female used the product. She broke out in red blotches that itch 

wherever there was no clothing (where her neck, arms and legs were 

exposed). She used Benadryl and cortisone and alcohol on the areas where 

it continued to spread. She went to the ER and was given medication that 

was helping.

022376 - 9/5/2010 ZACHARY, LA US MODERATE A 13 year old female used the product for about an hour on her left side. 
Page 11 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

Chemical: Metofluthrin PC Code: 109709

Incident 

Package 

Report

Incident 

Date Location Country

Exposure 

Severity Incident Description

00006 She bathed afterwards for 15 minutes. About 5 hours later woke up with 

pruritic hives on her left side, left thigh and both arms. The hives seem to be 

spreading. They have used Swan Clear anti-itch lotion on the areas. She 

went to the emergency room. They advised that it was probably an allergic 

reaction and recommended Benadryl and caladryl. The rash was improving, 

but then came back and spread on her leg and face. She was going to see 

a dermatologist.

023081 -

00001 5/28/2011

MIDDLEBURY, 

VT US MODERATE

An adult female used the product for the first time 4 days ago. After using 

the product while gardening for about 4 hours, caller began to feel her 

tongue swelling. Swelling worsened over the next 2 hours, and caller began 

coughing and felt short of breath. She began using her asthma nebulizer 

and administered an epi-pen at home. Symptoms improved with treatment, 

but she continued to use her nebulizer over the next few days feeling some 

tightness in her chest. She is just feeling better at the time of call. She did 

not see MD for evaluation.

023081 -

00010 6/14/2011 HAMPDEN, MA US MODERATE

A 60 year old female used the product yesterday (attached to her shirt) 

evening outdoors. Her face/neck became red and she found her BP to be 

about 240/110 and HR about 90. She showered and went to ER, where she 

was kept overnight. MD diagnosed her with an allergic reaction to the 

product. Within 24 hours her Sx dissipated.

023081 -

00015 6/18/2011 SHELTON, CT US MODERATE

A 65 year old female used the product while camping in Maine. She did not 

realize tire batteries were dead. She was bitten by gnats and black flies and 

experienced redness and swelling under her eyes and on the left side of her 

face and the back of her neck. She was taken to urgent care where she was 

given prednisone injection and Benadryl. Two day later, went to see her 

own doctor today, swelling was still present but resolving.

023081 -

00027 6/26/2011 MERRILL, WI US MODERATE

Caller clipped the product on her 2 year old daughter's stroller 2 days ago in 

the evening for a few hours. The next morning she woke up and had a rash 

from head to toe. She went to MD that night for the rash. MD recommended 

ibuprofen for a fever. MD ruled out heat rash and chicken pox. Blood work 

to rule out platelet and WBC levels.

023081 -

00031 6/26/2011 KEWANEE, IL US MODERATE

A 7 year old female was wearing the product on her belt loop. She began to 

widen her eyes as they looked off to the side. She was having neck 'ticks' 
Page 12 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

Chemical: Metofluthrin PC Code: 109709

Incident 

Package 

Report

Incident 

Date Location Country

Exposure 

Severity Incident Description

while she

was looking away. The same symptoms occurred on and off the next day. 

The following day, she was taken to E.D. She had a CAT scan performed 

which was unremarkable. She saw her pediatrician who thinks the eye 

movements are due to wearing the product and the ingredients in the 

product ClipOn. 

023081 -

00032 6/24/2011

MOUNT 

LAUREL, NJ US MODERATE

A 70 year old male used the product daily for about 2 weeks. He developed 

a rash on his back and shoulder. He went to his MD and was diagnosed 

with shingles.

023228 -

00019 7/6/2011 HOUSTON, TX US MODERATE

The caller stated that she used the product on 7/6 and accidentally touched 

the liquid and then touched her eye. Since then she has been experiencing 

ocular redness and irritation. She did rinse not rinse her eye after the 

exposure but did rinse her eyes on 7/9. Symptoms did not improved and 

she was seen by her MD on 7/11 and was prescribed and ocular ointment

(contained steroid and antibiotic). She has been following the MD 

recommended treatment and she is wondering if anything else can be done 

for treatment. Symptoms resolved.

023228 -

00025 7/10/2011

WINFIELD 

PARK, NJ US MODERATE

Caller wore the product on her shirt. 2 or 3 days later, she noticed an itchy 

rash on her arms and torso. She contacted MD by phone (was not 

examined), who prescribed 'fungus cream.' She began applying this on 7/14 

with relief of the itch, but the rash remains. She has discontinued use of the 

cream and has appointment with MD fortmoderateoming. Caller was 

evaluated by her MD, but does not recall MD diagnosis. MD prescribed oral 

Prednisone for treatment. Symptoms immediately began to improve and 

have almost completely resolved with treatment.

023228 -

00026 7/13/2011

NEW 

MEADOWS, ID US MODERATE

Caller and family used the product 5 days ago while camping. Caller's son 

was bitten by mosquitoes on his arms and legs. The following day, son had 

severe itching on tile bug bites, and caller gave son Benadryl to try to ease 

symptoms. When they returned home from camping a few days ago, son 

was evaluated by MD. Son was given a steroid injection, and they used 

calamine lotion to help ease symptoms. Symptoms have resolved with 

treatment. 

023313 - 7/28/2011 CEDAR KNOLLS, US MODERATE An adult female had the product under her seat at a concert last Thursday. 
Page 13 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

Chemical: Metofluthrin PC Code: 109709

Incident 

Package 

Report

Incident 

Date Location Country

Exposure 

Severity Incident Description

00001 NJ She touched the inside of the product. She did not wash her hands 

immediately. Later on that night she developed a rash to her chest, back 

and scalp. The product did not have direct contact with these areas. She 

went to MD and was put on oral prednisone and she is to take oatmeal 

baths. On callback she is doing better but her rash is still healing. She still 

has the rash on her chest a bit, it is worst at night. Her scalp also itches a lot 

at night. She is following up with her MD and used the prednisone as 

prescribed. 

023313 -

00002 7/19/2011 SUSSEX, NJ US MODERATE

The caller reports that he used the product 2 weeks ago and developed a 

headache for 1 week. He discontinued use and sought medical care. He 

had a CT scan performed which shown no significant findings. They 

prescribed Naproxen for the discomfort which did help alleviate the 

symptoms. He used the product again tonight and developed the same 

headache. On call back, Richard was feeling better and doing fine. He has 

discontinued use of the product and that seems to be helping a lot. He only 

gets severe headaches when he was using the product and he's sure that 

there is some ingredient in the product that is causing these severe 

headaches. 

023313 -

00004 7/29/2011 MALVERN, AR US MODERATE

Caller's husband started using product on 7/28/2011. Caller does not have 

packaging with her. She states that her husband developed 'rashes and 

hives' on 7/29/2011 and that he was just seen by a dermatologist. 

Dermatologist treated husband with unknown injection, and symptoms have 

been improving with treatment.

Caller said she was very busy and did not wish to talk further.

023313 -

00025 8/22/2011 LIVONIA, MS US MODERATE

Caller was using the product 2 days ago. She had the area clipped on to the 

neckline of her shirt. About 24 hrs later, she developed 3 hive-like bumps on 

her chest. She applied some Cortisone cream to the site. Caller also thinks 

that the product wasn’t working and that the welts/hives might actually be 

mosquito bites.

023409 -

00004 7/26/2011 DENVER, CO US MODERATE

Caller reports he used product about 6 weeks ago and about immediately 

developed a cough. Caller sought MODERATEP care and was hospitalized 

and told he had a heart problem caused by lung issues that developed as a 

result of product use. Caller was hospitalized for about I week and is now 
Page 14 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

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recuperating.

023409 -

00016 9/10/2011

SAN ANTONIO, 

TX US MODERATE

Caller used the product on Friday. When he inserted the product into the 

unit, some of the green fluid got on his hands, and then he proceeded to eat 

without washing his hands. The next day, he became ill with nausea, 

diarrhea, malaise and muscle cramps. This has lasted for the past 2 days.

023409 -

00018 9/2/2011

CHAPLE HILL, 

NC US MODERATE

The caller stated that she used the product for the first time on 9/2/11 and 

that evening she developed hives on her stomach, legs and back. She was 

seen by her MD and was prescribed Prednisone and was diagnosed with 

having an allergic reaction. 

023409 -

00026 9/16/2011 ALBANY, LA US MODERATE

Caller states her husband used the product on Friday and within an hour, 

she noticed that her husband's face and neck were red and his back was 

red and blotchy. That night, they called poison control and they told him to 

shower. After his shower, he had red raised hives on back, chest and neck 

and some of them were peeling. Husband has doctor's appt tomorrow.

024299 -

00013 6/14/2012

NEW 

ALEXANDRIA, 

PA US MODERATE

Caller states that her 35 year old daughter attached the product to her waist 

1 hour ago. Within a few minutes she developed irritation in her left eye. 

Caller is thinking she got product on her hand and then rubbed her eye. 

Caller's daughter flushed the eye for 5 minutes, applied cool compresses 

and took Tylenol. No eye drops were applied. Caller is concerned because 

her daughter had 2 eye surgeries in the past so she has sensitive eyes. 

Daughter is still experiencing a burning sensation. She is not sure that her 

daughters symptoms had anything to do with the Off! Product. Went to 

emergency room later that night due the fact that she was so much pain. 

They found scratches on her corneas. Symptoms lasted about 3 days. 

Daughter is doing fine now.

024299 -

00017 6/2/2012

SUMMERVILLE, 

SC US MODERATE

Caller states that he has been using the product on a table next to him for 

about 2 weeks. Two weeks later, he felt hand tingling and his lips felt numb. 

He called his V .A. nurse and was told to go to the hospital. He went to E.D 

and got a Ct scan. CT scan was unremarkable. He was diagnosed 

'Complicated migraine headaches'. He was not given any medications. 

Caller has a doctor appointment follow up this week. 

024438 -

00001 7/2/2012

GREENFIELD, 

MA US MODERATE

Caller states he inadvertently touched refill/disk about 2 hours ago. Caller 

states he feels 'strange with not clear thinking' and a 'different' breathing 
Page 15 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

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pattern but not quite SOB. Caller states he has had previous Sx of fatigue. 

024438 -

00002 6/30/2012 CHESTER, PA US MODERATE

Caller states she used the product in the evening of 6-30-12. It was sitting 

on her lap on top of her sweater while running for a half hour. She put her 

jacket back on. She woke up with beet red skin and welts on her arms,

chest, and legs, leg weakness, neck and throat irritation, lethargy, heart 

palpitations. One day ago she went to dermatologist who gave prednisone, 

Claritin, and cream to apply. He took blood. She is to call him today for 

results. Skin is not as red and she is feeling much better today. Caller states 

it was her fault, she did not read the instructions. 

024438 -

00004 7/1/2012 OK US MODERATE

Caller states that she began using the product 1-2 times per day by clipping 

it to her shirt about 2-3 weeks ago. On 6/30/12 or 7/1/12, she developed 

itchy red rash on her neck, which spread to her chest. She was seen by MD 

on 7/2. MD advised her to discontinue use of Nopolea and Ambien, and 

prescribed triamcinolone cream. No diagnosis was made. Caller has 

showered. Itching has improved with the cream. Today, it occurred to caller 

that perhaps she should not have clipped the product to her shirt. 

024438 -

00012 6/29/2012 WINNIPEG CN MODERATE

Caller used the product in the evening while camping. Caller estimates that 

she used the product for 5 min total, 2-3 min then turned the product off 

then used for another 2-3 min. The next morning (6-8 hours after use) she 

experienced extreme itching on the palms of her hands and soles of her 

feet. Caller states that shortly after she woke up she passed out for a short 

period of time. When she woke back up she felt nauseous and had some 

diarrhea. The caller tried to walk to the car but found that she was unable to 

move her legs. The caller was carried to the car and taken to an emergency 

room. Several tests were done including EKG monitoring, unspecified blood 

work and CT scan. Caller states the physician was concerned that she had 

a mild stroke. All tests came back normal Caller was kept for observation 

and unknown medications during the day and was released early in the 

evening with no medication. Caller states that the intense itching resolved 

approx 1 hour after arriving at the hospital. Caller states that she was 

asymptomatic within 24 hours of initial exposure. Her physician informed her 

that the intense itching could be related to her inhaling a poisonous gas.

024438 - 7/31/2012 PHILIPSBURG, US MODERATE Caller states that 4hrs prior to the call she turned the product on with her 
Page 16 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

Chemical: Metofluthrin PC Code: 109709

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00035 MT right hand. She states she did not touch any of the product inside the clipon. 45min after turning it on, her hand became itchy and started to swell. 

45min after symptoms began, she took a Benadryl She states the Benadryl 

has resolved her itching, but her hand remains very swollen at the time of 

the call. She has washed the hand for an unknown amt of time and has tried 

applying ice.

024514 -

00009 8/6/2012

POINT 

PLEASANT 

BEACH, NJ US MODERATE

Caller states that 2wks prior to the call she was sitting in her gazebo with 

the product and states she was still getting mosquito bites. Caller states that 

because she was still getting mosquito bites she held the product blowing at 

her legs 3-4in away from her legs. Caller states that that same day around 

each of the mosquito bites she developed pink spots. Caller states her 

symptoms spread over her legs. She tried applying caladryl for her 

symptoms but they persisted and she went for a dermatology consult and 

was told she has contact dermatitis. She was given a topical ointment to 

apply, but states her symptoms have gotten worse and her legs are now 

blistered with dark red spots that itch, burn and 2days prior to the call have 

spread down to her feet. 

024514 -

00012 8/16/2012 SMITHVILLE, TX US MODERATE

An adult male was at a picnic and the product was clipped onto the back of 

his lawn chair. While sitting out for a few hours, he developed watery, 

irritated left eye. They left the party and went to the gas station for saline 

solution to rinse his eye. His eye was now red and irritated. He went home 

and he removed his left contact lens. He had a 'cloudiness' to his vision. The 

symptoms persisted and he developed a swollen left eye by the next 

morning. He went to Optometrist and was given steroid eye drops. The 

Optometrist said there was 'bumps' of the OFF! ClipOn ingredients on his 

cornea. The eye doctor stated that his soft contact absorbed the product 

ingredient and caused the symptoms. On 8/19 he went to the E.D because 

his vision was not improving and symptoms seemed to worsen. The E.D 

doctor gave him antibiotic eye ointment and a pain medication. Several days 

later he had another appointment with Optometrist who examined his left 

eye and still saw cloudiness to the cornea. He has future appointments with

eye doctor. 

024514 - 8/17/2012 ANNISTON, AL US MODERATE Caller reports that she was wearing the product when she came into the 
Page 17 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

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00014 house this past Friday evening. She had worn it outside without incident, 

and that she switched the product off and left it on her bedside table. She 

woke up six hours later and noticed that the product had been switched on. 

On Saturday morning, she noticed that her throat felt irritated, and since 

then she has felt lightheaded, and has not gotten out of bed since then. She 

developed diarrhea this morning. She tried to sit on her front porch to get 

fresh air, and that she has taken Maalox and Benadryl, with no relief of her 

symptoms. She does have a ceiling and tower fan in her bedroom, and that 

the room is well-ventilated. She did not think that the product had a strong 

odor, and that she has called a poison center, and was told that the product 

active ingredient has a wide margin of safety, but she can see that the 

product has a warning label on It that indicates that it can be hazardous to 

humans. 

024514 -

00033 7/30/2012 BARRIE CN MODERATE

Caller states that over a month ago while out to eat at a restaurant the 

product was used. Pt had looked at product and then had a syncopal 

episode, ambulance was called and pt was transported to hospital, pt's EKG

was normal, MRI was fine, chest X-ray was fine. Pt had a cardiac follow up 

with a specialist where he wore a heart monitor for 48 hours and that was 

also fine. 

024745 -

00009 10/2/2012 RENO, NV US MAJOR

Caller and her husband felt ill following use of the product. Nausea, 

coughing, vomiting, and sweats symptoms started a couple of hours later. 

Went to the ER 1 days later. MD stated this may have caused the heart 

attack but were not certain, had to have breathing treatments (unknown 

what kind). Caller was not certain what treatments were done for her 

husband. Husband was in the hospital for 7 days. Had a stress test done, 

angiogram, echocardiogram. Has been started on Plavix since being in the 

hospital is doing better now. She became nauseous the following day. She 

noted that she did not like the smell of the product and did not use it as long. 

They have discontinued use of the product She has also remained 

asymptomatic.

025483 -

00018 6/14/2013 LINCOLN, NE US MODERATE

An adult female used the product while camping. She had the product

clipped onto her shirt near her cleavage. She woke up the next morning 

after having the product attached to her and realized their skin was itchy. 
Page 18 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

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Her chest and stomach red, itchy and painful. She diaper rash cream, 

calamine cream, and cortisone cream to the rash. She went to the MD and 

was treated with Prednisone and Kejlex.

025483 -

00019 6/14/2013 LINCOLN, NE US MODERATE

An adult male used the product while camping. He has the product clipped 

onto his belt loop. He woke up the next morning after having the product 

attached him and realized his skin was itchy. He states that his skin near his 

groin was very itchy, red and painful. He used diaper rash cream, calamine 

cream, and cortisone cream to the rash. His symptoms are beginning to 

resolve.

025628 -

00013 5/25/2013

ANCHORAGE, 

AK US MODERATE

An 82 year old female with some recent complaints of eye problems that 

seem to have developed over the past 30-45 days on an intermittent basis. 

The pt companies of some occasional eye irritation and crustiness around 

the eyes in the morning as well discharge and wateriness. She had reported 

to them that she has worn one of the clip-on products up near her collar 

several times over the past few months and believes that she may have 

been exposed to it that way triggering these issues.

025628 -

00020 7/13/2013 WAUBAUSHENE CN MODERATE

Caller had product clipped in the v-neck of her shirt two days ago in the 

afternoon. Late that afternoon caller noticed bumps on her neck. She 

originally thought the bump was from a bite. The symptoms have spread 

and the area is now pimply. There is no open skin. Caller has used 

cortisone cream on the area but that has not helped. Putting something wet 

on the affected area makes it itchy. Caller is going to the doctor this 

afternoon for a Bl2 injection and plans to ask the nurse about the rash. 

Caller has previously used the product but it has been on a table or on her 

lap, not clipped to her shirt. Caller also said she does not see the 

ingredients on the package and would like to know what they are.

025628 -

00038 7/29/2013 TORONTO CN MODERATE

Caller used the product five times so far, this summer. I had started getting 

inexplicable tremors, dizzy spells, and nausea. I am in my early thirties, and 

healthy. She realized these symptoms, had only been present after the use 

of OFF. She stopped using it, and has not felt that way again. 

025763 -

00024 8/14/2013 EXETER, NH US MODERATE

A 26 year old female used the product overnight indoors 2 nights ago. It was 

6 feet from her face. She woke up 1 day ago with an abscess under her 

lower lip that is the size of a half dollar and swollen. She also had an open 
Page 19 of 19

Human Incidents Descriptions for OFF! CLIP-ON MOSQUITO REPELLENT (Reg. No. 4822-542)

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sore on outside bottom edge of her nostril, and a boil on the back of her leg.

She has applied witch hazel to both areas 2x. She went to the ED. She was 

given 2 prescription antibiotics. Dr said it was a 'massive allergic reaction to 

the bug spray. '