2.
Historical data on medicinal use
2.1.
Information on period of medicinal use in the Community
Melaleuca alternifolia oil has been used as medicinal by Australian Bundjabung Aborigines for several
millennia for bruises, insect bites, and skin infections. European colonists soon recognized the
therapeutic properties and began to distil oil from its leaves (Carson & Riley 2001). Members of the
crew of James Cook described at the end of the eighteenth century the use of the TTO. It was
rediscovered in the 1920s as a topical antiseptic with more effective activity than phenol (Bozzuto et
al. 2011).
The essential oil was distilled for the first time in 1925 and due to its antiseptic, antibacterial and
antifungal effects became a standard antiseptic agent for surgery, especially for dental surgery (Saller
et al. 1998).
The monograph on TTO of the
British Pharmaceutical Codex
of 1949 reports that TTO has germicidal
properties and has been used as a local application in the treatment of furunculosis, tinea, paronychia,
impetigo, trush and stomatitis, and as inhalant in coryza. In veterinary practice it has been used in the
treatment of mange and eczema and in sores and skin diseases of parasitic origin.
TTO has been used for its bactericidal and fungicidal properties as a disinfectant component in several
medicinal combination products with non-herbal ingredients authorised in UK since before 1970.
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A cutaneous liquid containing TTO has been authorised in Denmark from 1993 to 2009 for disinfection
in acne and in fungal infections on the foot.
In Sweden a cutaneous liquid is marketed since 1988 and a oromucosal and cutaneous solution is
registered in Hungary since 2004.
Table 2 shows a consistent and long standing use of TTO demonstrated for more than 30 years, since
1930, internationally and for more than 15 years, since 1933, in the European Community. A wide
range of traditional indications have been described for local application including the nasal, mouth and
throat regions.
TTO has been used as an antiseptic for special and general dental surgery and in denture and mouth
washes (MacDonald 1930, Anonymous 1933, Penfold & Morrison 1937, Penfold & Morrison 1950). It
has also been indicated for a variety of skin conditions including bacterial and fungal infections of the
skin such as acne, furunculosis, dermatophytosis (tinea pedis, tinea cruris, tinea barbae), pityriasis
versicolor (tinea versicolor), parionychia, impetigo, empyema, dermatitis, eczema, psoriasis, skin
rashes, impetigo contagiosa, pediculosis, ringworm, thrush, infected pustules, intertrigo and nail
infections (caused by Candida albicans), parasitic skin diseases (Penfold & Morrison 1937, Penfold &
Morrison 1950, Humphery 1930, Martindale 1993, British Pharmaceutical Codex 1949, Walker 1972,
WHO 2004).
Many different foot problems have been treated by TTO including onychomycosis infections of toenails,
bromidrosis, malodour, cracks, fissures, peeling, callused heels, inflammation of corns, calluses,
bunions, hammertoes, post-operative wound healing (Walker 1972, WHO 2004). It has also been used
for the treatment of infected, colonised, dirty wounds, diabetic gangrene and chronic leg ulcers, burns
and wounds (Penfold & Morrison 1937, Penfold & Morrison 1950, Humphery 1930, WHO 2004).
Throat, nasal and mouth conditions including acute nasopharyngitis, catarrh, thrush, stomatitis,
tonsillitis, mouth ulcers, sore throat, coughs and colds, nasopharyngitis, sinus congestion, tonsillitis,
pyorrhoea, gingivitis are traditional indications for use of TTO (Penfold & Morrison 1937, Penfold &
Morrison 1950, Humphery 1930, British Pharmaceutical Codex 1949, WHO 2004).
TTO has been used for vaginal infections and gynaecological conditions including vaginitis, cystitis and
cervicitis (Penfold & Morrison 1937, Penfold & Morrison 1950, Humphery 1930, WHO 2004), irrigation
of bladder and urethra (Anonymous 1933), symptomatic treatment of colitis (WHO 2004) and as an
inhalant in coryza (British Pharmaceutical Codex 1949).
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Table 2: Traditional use of tea tree oil
Reference
Documented Use / Traditional Use
Herbal
preparation
Posology
Safety
Comments
Humphery
1930
Australia
a) Cleaning of dirty or infected wounds
and pus dissolution
b) help wound healing
c) peryonichia.
d) as a gargle to clear up sore throats in
the early stages
e) for use in the vagina with no irritation
f) help in clearing head cold symptoms.
g) for nasopharynx
h) for several parasitic skin diseases
a)-f) 35% TTO
saponified solution
g) TTO diluted with
paraffin
a)
various water
dilutions commencing
from 2.5% to 10%
b)
2.5% dilution to be
applied as
impregnated dressing
and changed every
24 hours
c)
10% water dilution
d)
20 drops in a glass of
warm water
e)
Stronger dilutions
f)
a few drops inhaled
from handkerchief
g)
as a spray
h)
as an ointment
No apparent
damage to the
tissues even in
quite strong
solutions.
Infections that had
resisted treatments
of various kinds for
months were cured
in less than a
week.
MacDonald
1930
Australia
as an antiseptic for special and general
dental surgery
Ti-Trol – 100% TTO
Melasol – 40% TTO
in water soluble
emulsion
Anonymous
1933
Great Britain
a) Use in dental, medical and surgical
practice
b) Use in a wide range of septic conditions
c) for irrigation of bladder and the urethra
a), b) Ti-Trol (100%
TTO)
a)–c) Melasol (40%
TTO in water soluble
emulsion)
c) 100% Melasol solution
powerful non-
poisonous and non-
irritant disinfectant
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Penfold and
Morrison
1937
Australia
Extensive application in surgical and
dental practice.
Chronic leg ulcers and wounds
Germicidal even in presence of blood and
organic matter.
Peryonichia (paronychia), empyema,
gynaecological conditions, skin conditions
including psoriasis, impetigo contagiosum,
pediculosis, ringworm (tinea). Throat and
mouth condition including acute
nasopharyngitis, catarrh, thrush, aphthous
stomatitis, tonsillitis, mouth ulcers, sore
throat, pyorrhoea, gingivitis.
Ti-Trol (100% TTO)
Melasol (40% TTO
in water soluble
emulsion)
Ti-Trol quickly
healed an
unhealing head
wound;
Ti-Trol cleared
tinea in many
cases;
TiTrol and Melasol
healed leg ulcers
with pus not
responding to other
treatments;
Melasol healed a
chronic case of
diabetic gangrene
British
Pharmaceutic
al Codex
1949
Great Britain
Germicidal properties. Local application for
treatment of furunculosis, tinea,
paronychia, impetigo, eczema, thrush,
stomatitis. Inhalant in coryza.
TTO
Stored in well-
closed containers,
protected from
light and in a cool
place
Penfold and
Morrison
1950
Australia
Extensive application in surgical and
dental practice.
Germicidal even in presence of blood and
organic matter.
Perionychia (paronychia), empyema,
gynaecological conditions, diabetic
gangrene.
Skin conditions including psoriasis,
impetigo contagiosa, pediculosis,
ringworm (tinea).
Throat and mouth condition including
acute nasopharyngitis, catarrh, thrush,
aphthous stomatitis, tonsillitis, mouth
100% TTO or a
water soluble oil
emulsion without
relating to a specific
indication
Pleasant odour,
non-poisonous,
non-irritant, non-
corrosive. Ability to
penetrate pus, acts
to deslough,
leaving a healthy
surface. The
germicidal activity
is maintained and
even increased in
presence of organic
matter.
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ulcers, sore throat, pyorrhoea, gingivitis.
Skin injuries and abrasions.
Antiseptic agent in denture and mouth
washes.
Walker
1972
USA
Common foot problems:
onychomycotic toenails
Ti-Trol – 100% TTO
To be applied twice daily
helps make nails
smoother and
firmer but had little
effect on organisms
Walker
1972
USA
Common foot problems:
a) bromidrosis
b) deodorant, healing of cracks and
fissures, peeling and callused heels ,
inflammation of corns, calluses, bunions,
hammertoes
c) Post-operative wound healing of
chemical matricectomies and post-surgical
sutured wounds
d) Relief of post-treatment dryness
following copper sulphate iontophoresis for
tinea pedis
e) fungal preventative associated with
tinea pedis
Melasol (40% TTO
in water soluble
emulsion)
e) 8% TTO in
ointment
preparation
apply once daily or
hydrotherapy
daily application to the
affected areas
post-operative dressing,
to be applied twice daily
Martindale
1982
UK
Added to many disinfectant preparations
TTO
Stored in cool
place in air-tight
containers,
protected from
light
Martindale
1993
UK
Reported to have bactericidal and
fungicidal properties and is used topically
for various skin disorders
TTO
Stored in air-tight
containers,
protected from
light
World Health
Uses supported by clinical data: topical
TTO
external application at
Contraindicated
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Organization
2004
International
application for symptomatic treatment of
common skin disorders such as acne, tinea
pedis, bromidrosis, furunculosis and
mycotic onychia (onychomycosis) and of
vaginitis due to Trichomonas vaginalis or
Candida albicans, cystitis and cervicitis.
Uses described in pharmacopoeias and in
traditional medicine: as an antiseptic and
disinfectant for the treatment of wounds.
Uses described in folk medicine:
symptomatic treatment of burns, colitis,
coughs and colds, gingivitis, impetigo,
nasopharyngitis, psoriasis, sinus
congestion, stomatitis, tonsillitis
concentrations of 5-
100%, depending on skin
disorder being treated
for cases of
known allergy to
plants of the
Myrtaceae family.
Not for internal
use. Keep out of
reach of children.
Store in a well-
filled airtight
container,
protected from
heat and light
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2.2.
Information on traditional/current indications and specified
substances/preparations
The leaves were macerated in water for a long period (hours or even days) and then used as infusion
or impregnated dressing especially in treating common cold, sore throat, insect bites, wounds or fungal
skin infections as well as in delousing (Saller et al. 1998).
The essential oil had been used during the Second World War as a general antimicrobial agent and
insect repellent, and provided in the first aid kits of serving Australian soldiers. The essential oil is
nowadays used as a strong antimicrobial and antifungal agent in creams, soaps, toothpastes and other
preparations and it has been used both externally and internally by both herbalists and
aromatherapists (Lis-Balchin et al. 2000).
In modern times, TTO is reputed to have several medicinal properties including antibacterial,
antifungal, antiviral, anti-inflammatory and analgesic properties. For its antibacterial activity is today
popular as a topical antimicrobial agent (Carson et al. 1998). It has been recommended in the
treatment of many cutaneous conditions, including acne, eczema, furunculosis, onychomycosis and
tinea (Carson et al. 2006).
TTO enjoys remarkable popularity as a topical antimicrobial agent and, although it is marketed mainly
for its well-documented antibacterial, antifungal and antiviral properties, the oil also has anti-
inflammatory, analgesic, insecticidal and antipruritic properties (Edmonson et al. 2011). Currently it is
also incorporated as the principal antimicrobial or as a natural preservative in many pharmaceutical
and cosmetic products intended for external use (Cox et al. 2000).
TTO has a number of characteristics which suggest potential for its use in wound treatments or
protectants against fly strike. It has documented insecticidal effects, which could be of use in the
treatment of larvae in strikes, and repellent effects (Callander & James 2011).
In Australia, it has also a long history of clinical use in the treatment of foot problems such as tinea
pedis and toenail onychomycosis. Dermatologic studies have been conducted in the treatment of acne,
dandruff, head lice, and recurrent herpes labialis, in which effects were found to be either similar or
better than traditional treatment, and often with fewer side effects. A few published studies report the
successful use of TTO in treating mucous membrane infections, including Trichomonas vaginalis, and
against oral bacteria and oropharyngeal candidiasis (Halcon & Milkus 2004).
In Denmark it has been authorised for disinfection in acne and in fungal infections on the foot (1993-
2009).
In Sweden TTO is used against itch at mild athlete´s foot, for uncomplicated insect bites and for
treatment of mild acne, in Hungary for treatment of skin infection, stomatitis, gingivitis, cut wounds,
excoriation and acne.
2.3.
Specified strength/posology/route of administration/duration of use
for relevant preparations and indications
TTO is usually topically applied at concentrations 0.05%-1.0% for treating microbial infections
(Combest 1999).
Tea tree preparations containing 10% and 100% TTO have been used in clinical trials to treat tinea
pedis and onychomycosis, respectively (Buck et al. 1994; Tong et al. 1992).
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For treating athlete’s foot, it is advised to dilute the concentrated oil with an equal amount of water or
vegetable oil and apply to the affected area three times a day with a cotton ball (Combest 1997). A
topically applied 5% solution appears to be effective in treating acne (Bassett et al. 1990).
Several published reports have addressed minimum inhibitory and bactericidal concentrations of TTO
against clinical isolates of Staphylococcus. aureus. A study of 105 clinical isolates of S. aureus using a
broth microdilution method found the MIC
90
(Minimal Inhibitory Concentration required to inhibit the
growth of 90% of organisms) of TTO to be 0.5%. A later study of 100 clinical isolates of methicillin-
resistant S. aureus (MRSA) found the MIC
90
of TTO to be 0.32% (Halcon & Milkus 2004).
For application on the skin TTO should always be diluted before use. In Sweden it is diluted in olive oil
or baby oil 1:9 and dabbed on the afflicted areas of the skin 1-3 times daily. The rate of dilution in
Denmark was 1:9 as well. The use is not recommended for children under 12 years of age. In acne or
athlete’s foot the maximum duration of use is 1 month of treatment.
In Hungary the daily dose for cutaneous use is 10-15 drops (corresponding to 0.33–0.5 ml or 0.3147-
0.47205 g) to be stirred in 50 ml of lukewarm water and the solution is applied on the skin with a
sterile cotton wool or gauze. In case of stomatitis and gingivitis 5-10 drops (corresponding to 0.17–
0.33 ml or 0.15735-0.47205 g) to be mixed in 100 ml of water for gargle several times daily (1 ml is
30 drops and 1g is about ~32 drops). If the symptoms do not improve after 5 days treatment the use
of products should be stopped.
Table 3: Information on preparations of TTO grouped according to the traditional use
Herbal preparation
Pharmaceutical form
Indication
Strength
Posology
Period of medicinal use
solution readily miscible in
water containing 35% of TTO
(saponified)
a) to dissolve pus, to
clean surface of
infected wounds
b) to wash or syringe
out dirty wounds to
loosen and remove
debris.
c) to help with
healing
d) as an ointment for
several parasitic skin
diseases
a) 35% TTO saponified
solution at various
water dilutions
commencing from
2.5%
b) 10% watery lotion
c) Dressings dipped in
2.5% solution to be
applied to wound and
changed every 24
hours
d) TTO diluted with
paraffin (no further
specification)
1930
Humphery
Australia
TTO for local application
Use as an antiseptic
for special and
general dental
surgery
100% TTO
or
40% TTO in water
soluble emulsion
(Melasol)
1930
MacDonald
Australia
TTO for local application
Extensive application
in surgical and dental
practice. Chronic leg
ulcers and wounds
including an ability to
Refers to 100% oil or
a water soluble oil
emulsion (Melasol)
without relating to a
specific indication
1937
Penfold and Morrison
Australia
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Herbal preparation
Pharmaceutical form
Indication
Strength
Posology
Period of medicinal use
penetrate pus, acts to
deslough, leaving a
healthy surface.
Germicidal properties
retained even in
presence of blood and
organic matter. Skin
conditions including
psoriasis, impetigo
contagiosum,
pediculosis, ringworm
(tinea).
TTO for local application
Impetigo
Not specified
1949 British Pharmaceutical
Codex (UK)
TTO for local application
Extensive application
in surgical and dental
practice. Ability to
penetrate pus, acts to
deslough, leaving a
healthy surface.
Germicidal properties
retained even in
presence of blood and
organic matter. Skin
conditions including
psoriasis, impetigo
contagiosa,
pediculosis, ringworm
(tinea). Skin injuries
and abrasions.
Refers to 100% oil or
a water soluble oil
emulsion (Melasol)
without relating to a
specific indication
1950
Penfold and Morrison
Australia
TTO for local application
Added to many
disinfectant
preparations
No further
specification
1982
Martindale (UK)
Cutaneous liquid
for uncomplicated
insect bites
TTO diluted in olive oil
or baby oil 1:9 (10%)
and dabbed on the
afflicted areas of the
skin 1-3 times daily.
Maximum duration of
use 1 month.
Not recommended for
children under 12
years of age.
Since 1988 (Sweden)
TTO for local application
used topically for
various skin disorders
for its bactericidal
No further
specification
1993
Martindale (UK)
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