Rx Balance Organic Tea Tree Oil by SunOpta Inc

POSSIBLY EFFECTIVE

• Acne. Some clinical research shows that topical tea tree oil seems to improve symptoms of acne in adults and adolescents. Details: Some preliminary clinical research shows that applying a tea tree oil 5% gel is as effective as benzoyl peroxide 5% (Oxy-5, Benzac AC, and others) and more effective than placebo for treating acne. Tea tree oil might work more slowly than benzoyl peroxide, but it seems to be less irritating to facial skin (8573). Other clinical research shows that applying a tea tree oil 5% gel for 20 minutes twice daily for 45 days decreases acne lesions 3.6-fold, acne severity 5.7-fold, and comedone numbers, pustules, and papules when compared with placebo in patients with mild to moderate acne (19176). Another small clinical study in patients with mild to moderate acne shows that applying a topical tea tree oil nanoemulsion with adapalene gel 0.1% once daily for 12 weeks reduces acne lesions and improves acne severity scores when compared with adapelene gel alone. However, the tea tree oil product was associated with an increased occurrence of mild adverse effects (109945). Conversely, a small clinical trial shows that applying tea tree oil 5% cream twice daily for 8 weeks reduces inflammatory acne lesions by 38%, compared with a 65% reduction in patients using a product based on Lactobacillus-fermented Chamaecyparis obtuse 5% cream. Additionally, the time of onset was slower with tea tree oil (91447).
• Onychomycosis. Some clinical research suggests that topical pure tea tree oil seems to be beneficial for onychomycosis. It is unclear if the diluted oil is beneficial. Details: Topical application of pure tea tree oil twice daily for 6 months can produce a mycological cure in about 18% of patients with toenail infections. It can also improve nail appearance and symptoms in about 56% of patients after three months and 60% of patients after 6 months of treatment. It seems to be comparable to twice daily application of clotrimazole 1% solution (1538). However, preliminary clinical research shows that lower concentrations of tea tree oil do not seem to be as effective. For example, there is some evidence that a tea tree oil 5% cream applied three times daily for 2 months has no beneficial effect (7032).
• Tinea pedis. Some clinical research suggests that topical tea tree oil 25% or 50% seems to be beneficial for tinea pedis, although it does not seem to work as well as standard treatments. Details: Topical application of tea tree oil 25% or 50% solution twice daily appears to produce both clinical improvement and a mycological cure in 48% to 50% of patients after 4 weeks of treatment, compared with 13% of those using placebo (10033). However, tea tree oil 25% or 50% concentrations don't appear to be as effective for mycological cure as clotrimazole or terbinafine (13713). Also, although topical application of a tea tree oil 10% cream seems comparable to tolnaftate 1% cream for relieving symptoms of tinea pedis, including scaling, inflammation, itching, and burning, the tea tree oil cream appears no more effective than placebo in producing a mycological cure (4031).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Angular cheilitis. Although there is interest in using topical tea tree oil for angular cheilitis, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Bacterial vaginosis. Although there is interest in using intravaginal tea tree oil for bacterial vaginosis, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Blepharitis. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with seborrheic blepharitis shows that using a specific topical swab (TTO Thermal Swab, Jeomed Medicine and Health Production Company) containing tea tree oil and chamomile twice daily for 8 weeks improves blepharitis symptom scores, such as burning, itching, and dry eyes, when compared with using baby shampoo. Symptom improvements were maintained 4 weeks after treatment discontinuation (109944).
• Contact dermatitis. Preliminary clinical research suggests that topical tea tree oil is beneficial for nickel-induced contact dermatitis. Details: Preliminary clinical research shows that undiluted or diluted tea tree oil for 3-5 days may reduce the area and redness of acute contact dermatitis reactions in people with nickel hypersensitivity (16337,19191). Other preliminary clinical research in individuals with nickel allergy shows that applying 60-120 mcL of tea tree oil 20% or 50% (Australian bodycare tea tree oil, Maxmedica AB) once, immediately prior to nickel exposure, reduces nickel-induced contact dermatitis by 41% when compared with no treatment (19191).
• Dandruff. It is unclear if topical tea tree oil is beneficial for dandruff in adults and adolescents. Details: Preliminary clinical research shows that a tea tree oil 5% shampoo, used for three minutes daily prior to rinsing for 4 weeks, reduces the total area and severity of scalp lesions, as well as the severity of dandruff, itchiness, and greasiness, by 23% to 28% in patients aged 14 years and older. However, it does not improve scalp scaliness (19178).
• Dental plaque. It is unclear if brushing or rinsing with tea tree oil is beneficial for dental plaque; the available evidence is conflicting. Details: Preliminary clinical research shows that brushing with a tea tree oil 2.5% gel twice daily for 8 weeks reduces papillary bleeding, but does not improve gingival health or plaque, in patients with plaque-induced gingivitis (19179). Other preliminary clinical research also shows that using tea tree oil mouthwash does not reduce plaque formation following a professional tooth cleaning (19180). However, a small preliminary clinical trial shows that using a mouthwash made from 3-4 drops of pure tea tree oil in water 2-3 times daily after brushing for 14 days is as effective as using a mouthwash containing chlorhexidine 0.12% twice daily for reducing plaque (105241). Some preliminary clinical research has also evaluated tea tree oil in combination with other ingredients. A combination of tea tree oil 1.5% and xylitol 10% (Tebodont) for 3 months reduces plaque formation on tooth surfaces when compared with pretreatment (19181). Other research shows that rinsing with 10 mL of a solution containing tea tree oil, clove, and holy basil 0.2% to 0.3% each, for 30 seconds twice daily for 21 days, reduces plaque formation by 64% when compared to baseline (91446). It is not clear if the effects in these studies are due to tea tree oil, other ingredients, or the combinations.
• Dry eye. It is unclear if topical tea tree oil is beneficial for improving symptoms of dry eye due to cataract surgery or meibomian gland dysfunction. Details: Clinical research in patients with dry eye due to cataract surgery also using artificial tears and topical steroid drops shows that eyelid scrubbing with eye shampoo containing an undisclosed amount of tea tree oil for one month improves symptoms of dry eye, such as sensitivity, pain, and blurred vision, and reduces demodex counts, when compared with using shampoo without tea tree oil. There was no benefit of the tea tree oil on visual acuity (101998). Clinical research in patients with meibomian gland dysfunction shows that applying a tea tree oil 1% shampoo around the eye once daily for 3 months improves gland function scores and dry eye symptom scores when compared with Johnson's baby shampoo (109943).
• Furuncles (boils). Although there is interest in using topical tea tree oil for boils, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Gingivitis. It is unclear if brushing or rinsing with tea tree oil is beneficial for gingivitis; the available evidence is conflicting. Details: A small preliminary clinical trial shows that using a mouthwash comprised of 3-4 drops of pure tea tree oil in water 2-3 times daily after brushing for 14 days is as effective as using a mouthwash containing chlorhexidine 0.12% twice daily for reducing plaque and bleeding and improving gum health (105241). Other preliminary clinical research in patients with severe gingivitis shows that brushing with a tea tree oil 2.5% gel twice daily for 8 weeks reduces papillary bleeding when compared with baseline. However, the gel does not appear to improve plaque or the severity of plaque-induced gingivitis (19179). Combination products containing tea tree oil have also been investigated. Preliminary clinical research shows that rinsing with a specific product containing a combination of tea tree oil 1.5% and xylitol 10% (Tebodont) for 3 months reduces gum inflammation by 26% to 32% when compared with pretreatment (19181). Also, clinical research shows that rinsing with 10 mL of a solution containing tea tree oil, clove, and holy basil 0.2% to 0.3% each, for 30 seconds twice daily for 21 days, reduces gum inflammation by 76% when compared to baseline (91446). It is not clear if the effects in these studies are due to tea tree oil, other ingredients, or the combinations.
• Halitosis. It is unclear if tea tree oil mouth rinses are beneficial for halitosis. Details: Preliminary clinical research in adults with halitosis shows that using a specific tea tree oil mouth rinse (100% Organic Tea Tree Oil, Dessert Essence) 10 mL twice daily for 7 days moderately improves halitosis severity scores and reduces salivary levels of Solobacterium moorei when compared with placebo. The improvements were similar to using chlorhexidine gluconate 0.2% mouth rinse (109941). Tea tree oil has also been studied as a combination treatment. One small clinical study suggests that applying an essential oil solution containing tea tree, peppermint, and lemon oils 0.125% as part of a single three-minute oral cleaning reduces the level of bad breath in patients from an intensive care unit when compared with baseline or benzydamine hydrochloride. 15 mL of the solution was applied to cotton sponges used to clean the teeth, tongue, and oral cavity (19177).
• Hemorrhoids. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in children with hemorrhoids shows that application of a specific gel (Proctoial, BSD Pharma) containing tea tree oil, hyaluronic acid, and methylsulfonylmethane (MSM) daily for 14 days decreases symptoms of hemorrhoids, such as anal pain, defecation pain, irritation, inflammation, visible bleeding, and itching, when compared with placebo (19318).
• Herpes labialis (cold sores). It is unclear if topical tea tree oil is beneficial for herpes labialis. Details: One small clinical study in adults with cold sores shows that applying a tea tree oil 6% gel five times daily does not improve the rate of cold sore resolution when compared with a placebo gel (2035). However, this study may have been inadequately powered to detect a difference between groups.
• Hirsutism. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with mild idiopathic hirsutism shows that using a spray containing lavender and tea tree oils twice daily for 3 months on specific hirsutism-affected areas decreases hair diameter by 8% to 9% and total hirsutism score by 11% when compared with baseline. The spray provides lavender oil 48 mcg and tea tree oil 2 mcg per square cm of skin. These improvements were not observed in a placebo group (91448).
• Insect bite. Although there is interest in using topical tea tree oil for insect bites, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Lice. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: There is preliminary evidence that tea tree oil repels lice and reduces blood feeding (19187). When used in combination with lavender oil, tea tree oil has ovicidal effects on head lice and reduces the number of live lice. A pediculicide containing tea tree oil 10% weight per volume and lavender oil 1% weight per volume (NeutraLice Natural Lotion, Key Pharmaceuticals Pty Ltd) has been applied to the hair for 10 minutes, either as a single application or three times over 2 weeks, in children aged 4-12 years (19188,19189). It is unclear if any effects are due to tea tree oil, lavender, or the combination.
• Methicillin-resistant Staphylococcus aureus (MRSA). It is unclear if topical tea tree oil is beneficial for the prevention of MRSA colonization or the treatment of MRSA infection. Details: Preliminary clinical research shows that tea tree oil is not effective for preventing MRSA colonization. Using tea tree oil 5% body wash (Novabac 5% skin wash, Novasel Australia Pty Ltd.) is no more effective than a standard wash (Johnson's baby softwash, Johnson & Johnson) for preventing MRSA colonization in critically ill patients (91441). There is contradictory evidence on the effects of tea tree oil for the treatment of MRSA infection. In patients with MRSA-colonized wounds, use of a 3% water-miscible solution of tea tree oil during the wound cleansing routine for each dressing change does not improve MRSA clearance (19190). Also, in patients with MRSA colonization, tea tree oil given in various preparations along with standard treatment for 5 days does not appear to increase overall MRSA clearance when compared with standard treatment alone. These various preparations, which contain tea tree oil 5% or 10%, include a cream applied to the nostrils three times daily, a body wash used at least once daily, or a cream applied to lesions, ulcers, wounds, and axillae or groin areas once daily. Although these various preparations do not improve overall clearance, it seems that using a tea tree cream and body wash may be more effective for eradicating MRSA from specific sites such as wounds and superficial skin infections when compared with standard treatments alone (19163). Also, preliminary clinical research suggests that using tea tree oil 4% nasal ointment plus tea tree oil 5% body wash increases MRSA clearance when compared with a triclosan body wash and mupirocin 2% nasal ointment (19158,19159). Larger, high-quality studies are needed to confirm these results.
• Ocular demodicosis. It is unclear if topical tea tree oil is beneficial for ocular demodicosis; available evidence is conflicting. Details: Small clinical studies suggest that tea tree oil can eradicate Demodex infestation in the eyelids and reduce associated symptoms such as corneal and conjunctival inflammation, ocular irritation, and vision loss. In adults, treatments have included weekly scrubs of the eyelid using tea tree oil 50% and daily scrubs of the eyelid with tea tree shampoo, as well as eyelid massages with tea tree ointment 5% to 10%, for up to 12 weeks (19182,19183,19184,19185,91445,105243). In children aged 2.5-11 years, weekly scrubs of the eyelid using tea tree oil 50% and daily eyelid massages with tea tree oil 5% ointment for 4-6 weeks has been used (19184). However, conflicting evidence exists. One meta-analysis of two randomized controlled trials shows that although patients using tea tree oil for 4-6 weeks were 68% more likely to have an eradication of mites, while another meta-analysis of three randomized controlled trials shows that the use of tea tree oil products does not reduce the number of Demodex mites or reported symptoms. Also, a single study shows that receiving intense pulsed light over 12 weeks is more effective than tea tree oil. The certainty of evidence for these endpoints is very low and the majority of available research has an unclear or high risk of bias (105243).
• Oropharyngeal candidiasis. It is unclear if rinsing the mouth with tea tree oil is beneficial for the prevention of oropharyngeal candidiasis in various populations. Details: One very small clinical study in adults with HIV/AIDS who are refractory to fluconazole shows that swishing and expelling tea tree oil solution 15 mL four times daily for 2-4 weeks seems to improve oral candidiasis when compared to baseline (4445). Another small clinical study in adults with terminal cancer shows that using tea tree oil, as part of an essential oil mixture containing geranium, peppermint, and lavender twice daily for one week improves subjective measures of oral comfort and objective measures of oral health status and reduces Candida albicans count when compared with saline solution (19192). However, in patients with dentures, adding 1 mL of tea tree oil to a standard 5 mL dose of Coe-Comfort tissue conditioner treatment for 12 days does not reduce inflammation or Candida albicans growth when compared with Coe-Comfort alone (19193).
• Otitis externa. Although there is interest in using tea tree oil in the ear for otitis externa, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Otitis media. Although there is interest in using tea tree oil in the ear for otitis media, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Pharyngitis. Although there is interest in gargling with tea tree oil for pharyngitis, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Rosacea. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with mild to moderate rosacea shows that applying permethrin 2.5% gel containing an undisclosed amount of tea tree oil to the affected area for one hour twice daily for 12 weeks reduces demodex mite counts by about 13% more than placebo. Furthermore, symptoms such as papules, burning, and redness were improved by moderate amounts when compared with placebo (101999). The effect of tea tree oil alone is unknown.
• Scabies. Although there is interest in using topical tea tree oil for scabies, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Seborrheic dermatitis. Although there is interest in using topical tea tree oil for seborrheic dermatitis, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Tinea corporis. Although there is interest in using topical tea tree oil for tinea corporis, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Toothache. Although there is interest in rinsing the mouth with tea tree oil for toothache, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Vaginal candidiasis. Although there is interest in using intravaginal tea tree oil for vaginal candidiasis, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Water warts. It is unclear if topical tea tree oil is beneficial for water warts in children. Details: Preliminary clinical research in children with a mean age of 6.3 years with water warts shows that a 4 mcL drop of an oil containing iodine plus Australian tea tree oil 75%, standardized to 40.1% terpinene-4-ol, applied twice daily for up to 30 days, increases lesion resolution when compared with tea tree oil or iodine alone (19194).
• Wound healing. Although there is interest in topical tea tree oil for wound healing, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose. More evidence is needed to rate tea tree oil for these uses.

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POSSIBLY SAFE ...when used topically and appropriately for up to 12 weeks (1538,4028,4031,4445,7032,8573,19157,19158,19159,19163)(19318,109944,109945).

LIKELY UNSAFE ...when used orally. Tea tree oil has been reported to cause significant toxicity when used orally (4028,10011,19166,19168,19170,109947).

CHILDREN: POSSIBLY SAFE
when used topically and appropriately. Tea tree oil 5% preparations have been used with apparent safety in children (8573).

CHILDREN: LIKELY UNSAFE
when used orally. Ingestion of tea tree oil can be toxic (4030,10010,10013,11799).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used topically and appropriately (512).

PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally. Ingestion of tea tree oil can be toxic (515).

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General ...Orally, tea tree oil can cause significant toxicity and should not be used. Topically, tea tree oil is generally well tolerated.
Most Common Adverse Effects:
Topically: Allergic reactions, burning, dryness, irritation, pruritus, redness, and stinging.

Dermatologic ...Ingestion of as little as 2. 5 mL of tea tree oil can cause petechial body rash. It can take up to a week for symptoms to resolve (10011).
Topically, tea tree oil is usually well tolerated. However, it can cause local irritation and inflammation in some patients. Treatment with topical corticosteroids may be needed in some cases (10033,13713,19176,91442,91443,109946,109947). Severe allergic contact dermatitis has also been reported (109948). Tea tree oil can cause skin dryness, and less frequently pruritus, stinging, burning, and redness in patients with acne (8573,91447,109947). It may also cause mild oral mucosal burning (4445).

Endocrine ...In one case, a prepubertal male who used a hair styling gel and shampoo product containing both tea tree oil and lavender oil developed gynecomastia. The gynecomastia resolved when the products were discontinued. It is possible that this effect was due to lavender oil, which has been associated with other cases of gynecomastia in prepubertal males (15254).

Gastrointestinal ...Orally, tea tree oil can cause eucalyptus-like odor on the breath. In young children, ingestion of 10 mL or less of tea tree oil can cause this effect (4030,10010,11799).

Hematologic ...Orally, as little as 2. 5 mL of tea tree oil can cause neutrophil leukocytosis. It can take up to a week for symptoms to resolve (10011).

Immunologic ...Orally, tea tree oil can cause or worsen systemic contact dermatitis (4028,19168). Topically, tea tree oil is usually well tolerated. However, it can cause allergic contact eczema and allergic contact dermatitis in some children and adults. Corticosteroids may be needed in some cases (658,4027,4028,4029,10015,10029,10030,10031,10032)(91443,105242,105244).
In young children, ingestion of 10 mL or less of tea tree oil can cause significant ataxia, drowsiness, disorientation, and coma (4030,10010,11799).

Neurologic/CNS ...Orally, tea tree oil can cause ataxia and CNS depression (109947).

Ocular/Otic ...There is some concern that topical use of tea tree oil in the middle ear for treatment of ear infections might cause ototoxicity. There is preliminary evidence from animal research that preparations of pure tea tree oil can cause ototoxicity and impaired hearing. However, so far there are no reports of ototoxicity in humans. Until more is known, tell patients to avoid pure or highly concentrated tea tree oil preparations. Concentrations of 2% seem less likely to have this effect (7025).

Pulmonary/Respiratory ...Orally, tea tree oil can cause dyspnea and pneumonitis (109947).

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