New incident report
Incident Report Number: 2019-5592
Registrant Reference Number: 2499539
Registrant Name (Full Legal Name no abbreviations): S.C. Johnson and Son, Limited
Address: 1 Webster Street
City: Brantford
Prov / State: ON
Country: Canada
Postal Code: N3T 5R1
Human
Country: CANADA
Prov / State: ONTARIO
PMRA Registration No. 29313 PMRA Submission No. EPA Registration No.
Product Name: OFF! Familycare Botanical Insect Repellent Lotion
Yes
Unknown
Site: Personal use / Usage personnel
Other
Sex: Male
Age: >1 <=6 yrs / > 1 < = 6 ans
System
>3 days <=1 wk / >3 jours <=1 sem
No
No
Unknown
Non-occupational
Application
What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity
None
Skin
<=15 min / <=15 min
<=30 min / <=30 min
8/12/2019 Caller applied the product to her son 1 week ago. He developed a rash, redness, and hives after product was rubbed on him. The rash and redness were gone the next day, but the hives were still there. Caller did give him Benadryl for treatment. Caller is not sure exactly how long the hives persisted, but they are gone now.
Moderate
Minor transitory dermatological symptoms may have multiple potential etiologies which, in addition to this product, include such factors as plant allergens, poison ivy, poison oak, food, infectious pathogens, heat exposure, insect bites, etc. Skin patch testing would be required before labeling this product as the causative agent. The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.