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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

TEA TREE OIL: 37 Adverse Event Reports & Safety Profile

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37
Total FAERS Reports
0
Deaths Reported
6
Hospitalizations
37
As Primary/Secondary Suspect
Shenzhen Shandian Jingling ...
Manufacturer

Route: TOPICAL · Manufacturer: Shenzhen Shandian Jingling Technology Co., Ltd. · HUMAN OTC DRUG · FDA Label: Available

First Report: 2005 · Latest Report: 20230924

What Are the Most Common TEA TREE OIL Side Effects?

#1 Most Reported
Drug ineffective
9 reports (24.3%)
#2 Most Reported
Hypersensitivity
7 reports (18.9%)
#3 Most Reported
Dyspnoea
7 reports (18.9%)

All TEA TREE OIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 9 24.3% 0 5
Dyspnoea 7 18.9% 0 5
Hypersensitivity 7 18.9% 0 1
Chest pain 6 16.2% 0 5
Lung disorder 5 13.5% 0 5
Pneumonitis 5 13.5% 0 5
Rheumatoid arthritis 5 13.5% 0 5
Vision blurred 5 13.5% 0 0
Visual acuity reduced 5 13.5% 0 0
Visual field defect 5 13.5% 0 0

Who Reports TEA TREE OIL Side Effects? Age & Gender Data

Gender: 70.6% female, 29.4% male. Average age: 58.0 years. Most reports from: US. View detailed demographics →

Is TEA TREE OIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 1
2016 4 0 0
2017 7 0 0
2019 2 0 0
2020 1 0 0
2023 1 0 0

View full timeline →

What Is TEA TREE OIL Used For?

IndicationReports
Product used for unknown indication 6
Fungal infection 5
Inflammation 5

Official FDA Label for TEA TREE OIL

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Lofuanna Fungal Nail Patches offers a quick repair solution that works overnight in just 8 hours, Ourpatches are hypoallergenic and specifically designed to fight fungal infections by addressing the rootcause, strengthening brittle nails, and visibly reducing discoloration. The patches are easy to applyand will securely adhere to the nail.

Dosage & Administration

Clean and dry the affected area before application. Remove the protective film and peel off the releasepaper from the patch. Place the sticky side of the patch directly onto the infected area of the nalil. Gentlyfold the sides of the patch around your toe or finger for secure adherence. Leave the patch on for 6-8hours, ideally overnight, to allow for effective treatment.

Warnings

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Active Ingredient

Active ingredients Tea tree oil 3% ------------------------------- Anti-fungal

Inactive Ingredients

Inactive Ingredients Water, Beeswax, Colloidal oatmeal, Cocos nucifera (coconut) oil, Elaeis guineensis(palm) oil, Calendula officinalis extract, Hydrogenated jojoba oil, Chrysanthellum indicum extract, Hydrogenated olive oil, Butyrospermum parkii (shea butter), Ceramide np, Mel, Propolis extract, Glycerin, Sorbitol, Sucrose, Lauric acid, Myristic acid, Sodium stearate, Sodium dodecyl sulfate, Propylene glycol.