MedPath

Tea tree oil

Generic Name
Tea tree oil
Drug Type
Biotech
CAS Number
68647-73-4
Unique Ingredient Identifier
VIF565UC2G

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 .

Background

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.

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
TOPICAL
0.006 mg in 30 mg
2025/04/28
84983-008
TOPICAL
42.5 mg in 1 g
2015/02/16
69594-004

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.

No HSA products found

No HSA products found for this drug

NMPA Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import

No NMPA products found

No NMPA products found for this drug

PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date

No PPB products found

No PPB products found for this drug

TGA Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient
50205
International Cosmetics Laboratories Pty Ltd
Active
1994/08/29
Melaleuca Oil
50165
International Cosmetics Laboratories Pty Ltd
Active
1994/08/25
Melaleuca Oil
195769
Active
2012/03/15
Melaleuca Oil
311820
Active
2018/11/22
Melaleuca Oil
381950
Active
2022/01/06
Melaleuca Oil
484428
Active
2025/03/27
Melaleuca Oil
474236
Active
2024/12/20
Melaleuca Oil
200806
Active
2012/09/08
Melaleuca Oil
52613
M H Nguyen
Active
1995/05/25
Melaleuca Oil
15674
Active
1991/09/12
Melaleuca Oil
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