Nouvelle déclaration d'incident
No de la demande: 2010-5215
Numéro de référence du titulaire d'homologation: 658991
Nom du titulaire (nom légal complet, aucune abbréviation): S.C. Johnson and Son, Limited
Adresse: 1 Webster Street
Ville: Brantford
État: ON
Pays: Canada
Code postal /Zip: N3T 5R1
Incident chez l'humain
Pays: CANADA
État: ONTARIO
Inconnu
ARLA No d'homologation 28648 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: OFF!Skintastic familycare Insect Repellant smooth and dry 113g-Canada
Oui
Inconnu
Site: Personal use / Usage personnel
Personne affectée
Sexe: Femme
Âge: >19 <=64 yrs / >19 <=64 ans
Système
>3 days <=1 wk / >3 jours <=1 sem
Oui
Non
Non professionnel
Application
Aucun
Peau
>3 days <=1 wk / >3 jours <=1 sem
>24 hrs <=3 days / >24 h <=3 jours
7/8/2010 11:34:03 AM Caller states that she has applied the product to her arms, legs and chest 6 times in the past week while working in her garden. She developed a rash to her arms, legs and chest within a few hours of using the product the second day. Her local Pharmacist recommended topical Benadryl applied to the rash. She has also taken an oral antihistamine. Follow-up on 7/22/2010 Patient states that her symptoms persisted for about 2 weeks, and caller saw MD for evaluation. MD prescribed a steroid cream for treatment of allergic reaction. Caller used the cream for a week and her symptoms completely resolved. After patient stopped using the cream, her rash returned despite not using the repellent anymore. She has started using the cream again and the rash has dissipated. She is now thinking something else is the cause since the rash has returned despite not using the repellent anymore.
Modérée
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. The differential diagnosis for dermatological disorders, especially during the warm weather months, would include multiple potential etiologies such as heat rash, sunburn, insect bites, viral infection, allergic reaction to sunscreens, allergic reaction to a consumed food or medication, and allergic reaction to a naturally occurring environmental allergen such as a component of a plant like poison ivy or poison oak. Also, given that the rash disappeared then reappeared again despite not using the insect repellent anymore there would appear to be another etiology involved.