Tea tree oil

Overview

Tea tree oil is an essential oil derived mainly from the Australian native plant Melaleuca alternifolia via steam distillation of the of the leaves and terminal branches . It may be referred to as Melaleuca alternifolia oil. It has been a popular ingredient in a variety of household and cosmetic products due to its antiseptic, anti-inflammatory, broad-spectrum antimicrobial and antioxidant properties . The dermatological use of tea tree oil has been investigated by various studies, where several studies have suggested the uses of this oil for the treatment of acne vulgaris, seborrheic dermatitis, and chronic gingivitis . Terpene hydrocarbons and related alcohols constitute tea tree oil, with Terpinen-4-ol being the major antimicrobial component .

Indication

Indicated for topical use to help protect against infection in minor cuts, scrapes, and burns. No FDA-approved therapeutic indications.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical and Microbiological Evaluation Of The Efficacy Of Herbal Mouthwashes in Gingivitis	2025/04/01	NCT06904742	Phase 4	Completed	Altinbas University
Efficacy of Locally Delivered Tea Tree Oil Gel as an Adjunct to Non-Surgical Periodontal Management	2023/04/07	NCT05803031	Not Applicable	Completed	Ain Shams University
Tea Tree Oil in the Treatment of Chronic Blepharitis	2010/02/23	NCT01073150	Phase 2	Completed	Federal University of São Paulo

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Eyelid Wipes	Shenzhen Shierjie Biological Engineering Co., LTD	43116-040	TOPICAL	0.04 U in 100 U	6/8/2025
Nail Fungus Treatment	TT Beauty Trading Co., Ltd.	85206-002	TOPICAL	0.03 mg in 30 mg	7/31/2025
Original Pain Relief Cream	Ultra Mix (Aust) Pty Ltd	69594-004	TOPICAL	42.5 mg in 1 g	2/16/2015
EELHOE Skin Tag Patches	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	85064-011	TOPICAL	0.144 mg in 144 mg	9/2/2025
SOUTH MOON Multi-Purpose Nail Solution	Shantou South Moon Biotechnology Co., Ltd.	84983-008	TOPICAL	0.006 mg in 30 mg	4/28/2025
XIMONTH Bee Venom Wart Remover Patch	Shantou Ximonth Biotechnology Co., Ltd.	84989-010	TOPICAL	0.0288 mg in 144 mg	9/9/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ONE 100% PURE TEA TREE OIL Melaleuca Oil 1mL/mL multipurpose liquid	50205	International Cosmetics Laboratories Pty Ltd	Medicine	A	8/29/1994
ONE TEA TREE OIL LOTION 15% Melaleuca Oil 150mg/g application bottle	50165	International Cosmetics Laboratories Pty Ltd	Medicine	A	8/25/1994
NeutraLice Natural Oils Spray	195769	Key Pharmaceuticals Pty Ltd	Medicine	A	3/15/2012
Eureka Tea Tree Water Soluble Solution	311820	Integria Healthcare Australia Pty Ltd	Medicine	A	11/22/2018
Brave Nature Antiseptic & Itch Relief Spray	381950	Esapharm Pty Ltd	Medicine	A	1/6/2022
Phys10 Ultra Armour Joint and Muscle Pain Relief Spray	484428	Twisobell Health Pty Ltd	Medicine	A	3/27/2025
Thursday Plantation Tea Tree Antiseptic Cream	474236	Homart Wellness Aust Pty Ltd	Medicine	A	12/20/2024
AeroAid First Aid Spray	200806	Aero Healthcare	Medicine	A	9/8/2012
PHOENIX OIL multipurpose liquid bottle	52613	M H Nguyen	Medicine	A	5/25/1995
THURSDAY PLANTATION TEA TREE OIL Melaleuca Oil 1mL/mL multipurpose liquid bottle	15674	Homart Wellness Aust Pty Ltd	Medicine	A	9/12/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ETHICAL HERBAL TEA TREE OIL	ashbury research corporation	02229700	Liquid - Topical	100 %	N/A
T40-C5 - LIQ 100%	melaleuca of canada inc.	02144115	Liquid - Topical	100 %	12/31/1995
T36-C7 - LIQ 100%	melaleuca of canada inc.	02144107	Liquid - Topical	100 %	12/31/1995
ACLEAR MEDICATED CLEANSING PADS	ashbury research corporation	02240290	Pad - Topical	25 %	N/A
MELA-GEL 23%	melaleuca of canada inc.	02048299	Gel - Topical	23 %	12/31/1994
TEA TREE PLUS ANTISEPTIC SOLUTION	tp health ltd.	02239448	Liquid - Topical	4 %	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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