(1RS,2RS,5RS)-(+/-)-5-Methyl-2-(1-methylethyl)cyclohexanol 1.7% • 2-(Methoxycarbonyl)pheno 12.5% • dl-Camphor 3.5% • Eucalyptus Globulus Oil . Other Ingredients: Liquid Parafin, Sodium Copper Chlorophyllin, Lavender Essential Oil.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
Below is general information about the effectiveness of the known ingredients contained in the product Hysan Lavender Relaxing Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Hysan Lavender Relaxing Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when used topically in low concentrations, short-term. Concentrations ranging from 0.1% to 11% seem to be safe for short-term application to intact skin (272,10327,89893). ...when used by inhalation, appropriately. Even relatively dilute concentrations of camphor can irritate the nose and sinuses. However, it is difficult to determine a safe concentration of inhaled camphor. The Occupational Safety and Health Administration (OSHA) has set a permissible workplace air exposure to synthetic camphor of no more than 2 parts per million (ppm) (272,105033). It is unclear how this correlates to the exposure obtained from a camphor balm or steam bath.
LIKELY UNSAFE ...when used topically on broken or injured skin. Application of camphor to broken skin can result in systemic absorption and toxicity (272). ...when inhaled in large concentrations, which can result in systemic toxicity (13445,39666). However, it is difficult to determine a safe concentration of inhaled camphor. The National Institute for Occupational Safety and Health (NIOSH) has determined an Immediately Dangerous to Life or Health Concentration (IDLH) of synthetic camphor in workplace air to be 200 ppm (105033). It is unclear how this correlates to the exposure obtained from a camphor balm or steam bath.
UNSAFE ...when used orally. Although a particular oral product containing camphor and hawthorn (Korodin Herz-Kreislauf-Tropfen) has been used safely by adults in some clinical studies (103620), ingestion of camphor can cause significant toxicity, including death (13442). Oral preparations of camphor are no longer available in the US (13442).
CHILDREN: POSSIBLY UNSAFE
when used topically (4814).
Young children might be more susceptible to the adverse effects associated with even minor systemic absorption of camphor. The American Academy of Pediatrics recommends that camphor not be used in treating children (4814).
CHILDREN: UNSAFE
when used orally.
Ingestion of camphor can cause significant toxicity including death (4814). The American Academy of Pediatrics recommends that available non-prescription topical camphor products should not exceed 11% strength to limit toxicity if accidentally ingested by children (4814).
PREGNANCY AND LACTATION: UNSAFE
when used orally.
Ingestion of camphor can cause serious toxicity including death (13442). There is insufficient reliable information available about the safety of using camphor topically during pregnancy and lactation.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Eucalyptus has Generally Recognized As Safe status (GRAS) for use in foods as a flavoring in the US (4912).
POSSIBLY SAFE ...when eucalyptol, a constituent of eucalyptus oil, is used orally and appropriately. Eucalyptol appears to be safe for up to 12 weeks (13302).
POSSIBLY UNSAFE ...when the undiluted oil is used topically. Prolonged or widespread exposure has caused neurotoxicity (12869). There is insufficient reliable information available about the safety of diluted eucalyptus oil when used topically.
LIKELY UNSAFE ...when the undiluted oil is ingested orally. Ingesting 3.5 mL of undiluted oil can be fatal in adults (12867). There is insufficient reliable information available about the safety of eucalyptus oil when inhaled as aromatherapy or when eucalyptus leaf is used orally in medicinal amounts.
CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods.
Eucalyptus has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
CHILDREN: LIKELY UNSAFE
when eucalyptus oil is used orally (12867,49002,107493,107495).
...when eucalyptus oil is used topically in infants and young children. There are reports of neurotoxicity in infants and young children exposed to topical eucalyptus oil. In one of these cases, a 12-month-old child was bathed in water containing eucalyptus oil and other essential oils; in another case, a child had a dressing containing eucalyptus oil applied every 2-4 hours daily for 2 days (12868,12869). ...when eucalyptus solutions are inhaled using a vaporizer (49002).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (4912).
There is insufficient reliable information available about the safety of medicinal amounts of eucalyptus oil; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Hysan Lavender Relaxing Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, concomitant use of camphor with other hepatotoxic drugs might increase the risk of liver damage.
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Theoretically, inhaling eucalyptol may reduce the effectiveness of amphetamines.
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Animal research suggests that inhaling eucalyptol may reduce the levels of amphetamines in the blood (48987).
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Theoretically, eucalyptus leaf might increase the risk of hypoglycemia.
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Animal research suggests that eucalyptus leaf might have hypoglycemic activity, and might have additive effects when used with antidiabetes drugs (12871).
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Theoretically, eucalyptus might increase the levels of CYP1A2 substrates.
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In vitro research suggests that eucalyptus oil might inhibit CYP1A2, although this has not been reported in humans (12479).
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Theoretically, eucalyptus might increase the levels of CYP2C19 substrates.
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In vitro research suggests that eucalyptus oil might inhibit CYP2C19, although this has not been reported in humans (12479).
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Theoretically, eucalyptus might increase the levels of CYP2C9 substrates.
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In vitro research suggests that eucalyptus oil might inhibit CYP2C9, although this has not been reported in humans (12479).
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Theoretically, eucalyptus might increase the levels of CYP3A4 substrates.
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In vitro research suggests that eucalyptus oil might inhibit CYP3A4, although this has not been reported in humans (12479).
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Theoretically, inhaling eucalyptol might reduce the effectiveness of pentobarbital.
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Animal research suggests that inhaling eucalyptol reduces the level of pentobarbital that reaches the brain (48987).
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Below is general information about the adverse effects of the known ingredients contained in the product Hysan Lavender Relaxing Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, camphor is unsafe and can cause significant toxicity.
Topically and by inhalation, camphor seems to be generally well-tolerated.
Most Common Adverse Effects:
Oral: Gastrointestinal and ocular symptoms of toxicity can occur within 5-90 minutes of ingestion. Neurological symptoms can occur with ingestion of quantities greater than 50 mg/kg.
Topically: Dermatitis and skin irritation.
Inhalation: Nose and sinus irritation.
Serious Adverse Effects (Rare):
All routes: Systemically absorbed camphor can lead to seizures, respiratory depression, coma, and death.
Cardiovascular ...Case reports of intoxication due to accidental or intentional consumption have included peripheral circulatory shock and sinus tachycardia (39649,97261). A 54-year-old female with a history of cardiomyopathy and atrial fibrillation developed several episodes of ventricular tachycardia and fibrillation requiring use of a defibrillator after ingestion of Vicks VapoRub, containing 4.8% camphor. She had been taking 7.5 grams of the product weekly, and took an additional 150 grams the week prior to admission. After discontinuing all camphor-containing products and receiving supportive measures, the patient's symptoms and laboratory abnormalities returned to normal (97260).
Dermatologic
...Orally, camphor can cause significant toxicity.
In more severe toxicity, general pallor and cyanosis of the lips occur (13442,13444). Topically, camphor is not as likely to cause adverse effects. But some amount of camphor can be absorbed through intact skin. Topical use of camphor has been associated with contact eczema (13445).
Warn patients not to heat products such as Vicks VapoRub in the microwave. Serious burns have occurred when the product is superheated in the microwave (13446).
Gastrointestinal ...Orally, camphor can cause significant toxicity. Symptoms of camphor toxicity occur rapidly within 5-90 minutes of ingestion. Burning of the mouth and throat, and nausea and vomiting are the first symptoms (13442,13444,39589,39626,39646,39658).
Hepatic ...Orally, camphor can cause transient elevations of liver enzymes in both adults and children. There is also a report of increased liver enzymes in an infant who received a camphor-containing topical cold remedy. The enzymes affected included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, and lactate dehydrogenase (LDH). The liver enzymes normalized after stopping the topical cold formula (4608).There is also a report of increased liver enzymes in a 35-year-old adult following "coining" with a balm containing camphor, which involves applying the balm and then rubbing the area with a coin until ecchymosis. The liver enzymes normalized after stopping treatment (39576). Elevated liver enzymes were also reported in a 54-year-old female after oral ingestion of Vicks VapoRub, containing 4.8% camphor. She had been taking 7.5 grams of the product weekly, and took an additional 150 grams the week prior to admission. After discontinuing all camphor-containing products and receiving supportive measures, the patient's symptoms and laboratory abnormalities returned to normal (97260).
Neurologic/CNS
...Orally, camphor can cause significant toxicity.
Neurological symptoms occur with ingestion of greater than 50 mg/kg. These symptoms include irritability, exaggerated tendon reflexes, tonic muscular contraction, myoclonic jerks, seizures, confusion, coma, and apnea. Seizures are sometimes the first manifestation of serious toxicity (13442,13444,39560,39589,39629,39646,39649,39658,39660). In children under 6 years of age, doses as low as 700-800 mg, and possibly as low as 500 mg, have caused serious seizures, resulting in respiratory failure and death (13442,13444,39589). Asymptomatic patients who have ingested camphor should be observed for at least 3 hours in a hospital. A 12-hour observation period may be prudent as seizures have occurred 9 hours after ingestion in apparently recovering patients. In patients who survive, symptoms usually resolve within 24 hours, although there are reports of persistent abnormalities for days to weeks. Long-term sequelae have not been reported after resolution of symptoms (13442,13443). In one case, a 10-year-old boy who intentionally ingested cold remedy transdermal patches containing a total of camphor 300 mg experienced mental status changes and tremulousness (39626).
Topically, camphor is not as likely to cause adverse effects, but small amounts can be absorbed through intact skin. A considerable amount of camphor can also be absorbed when inhaled. Excessive use of camphor, either topically or by inhalation, can result in the development of systemic toxicity (13445,39666). Topically and by inhalation, camphor has been associated with the occurrence of seizures. In one prospective observational study, there were 20 reports of new onset seizures and 29 reports of recurrent seizures in adults and children after use of camphor, either alone or in combination with eucalyptus oil. Most cases of seizure with topical use occurred 0.5-24 hours after topical application to the chest, neck, or face. Most cases of seizure with inhalation occurred about 2-30 minutes after steam inhalation of camphor (105028).
Ocular/Otic
...Orally, camphor can cause significant toxicity.
Ocular symptoms such as mydriasis and darkening of vision may occur (13442,13444). There is a case report of blurry vision following accidental ingestion of camphor (39667).
There is a case report of self-inflicted conjunctival inflammation after using camphor in the eyes (39624). Warn patients not to heat products such as Vicks VapoRub in the microwave. Eye injury has occurred when the product is superheated in the microwave (13446).
Pulmonary/Respiratory
...When inhaled in large enough concentrations, camphor can irritate the nose and sinuses.
However, it is difficult to determine a safe concentration of inhaled camphor (105033).
A 54-year-old females with a history of asthma developed shortness of breath, hypoxemia, and respiratory acidosis after oral ingestion of Vicks VapoRub, containing 4.8% camphor. She had been taking 7.5 grams of the product weekly, and took an additional 150 grams the week prior to admission. After discontinuing all camphor-containing products and receiving supportive measures, the patient's symptoms and laboratory abnormalities returned to normal (97260).
Other ...A smell of camphor from the breath and body have been reported following oral intake of camphor (39560,39589,97261).
General
...Orally, diluted eucalyptus oil is generally well tolerated, but the undiluted oil can cause toxicity.
Most Common Adverse Effects:
Orally: Diarrhea, nausea, vomiting.
Topically: Burning, itching, redness, stinging.
Serious Adverse Effects (Rare):
Orally: Signs of toxicity can occur with the undiluted oil at doses as low as 1 mL and include central nervous system depression, shallow respiration, rapid pulse, apnea, coma, and death.
Topically: Prolonged exposure or large amounts of eucalyptus oil can cause agitation, ataxia, drowsiness, muscle weakness, seizures, and slurred speech. The risk of toxicity may be greater in children.
Inhalation (as aromatherapy): Seizures.
Cardiovascular ...Orally, one case of premature ventricular contractions has been reported in a previously healthy 29-year-old male who ingested approximately one ounce of eucalyptus oil (48983).
Dermatologic ...Topically, eucalyptus pollen, leaves, oil, and the constituent eucalyptol can cause contact dermatitis in sensitive people (13303,48931,92856,92858,92859,98497). In some cases, symptoms respond to treatment with topical corticosteroids and tacrolimus (92856). In one case report, transient local redness, burning, and irritation was reported in a 4-year-old child who was bathed in water containing eucalyptus oil. The symptoms resolved within one hour of rinsing the skin with clear water (48983). In a clinical study, treatment with a combination of eucalyptus oil and lemon tea tree oil caused burning, redness, itching, or stinging in up to 20% of the patients. Stinging usually resolved within 10 minutes of application and redness within 30 minutes (19188,98492).
Gastrointestinal ...Orally, eucalyptus oil can cause nausea, vomiting, and diarrhea (48983,48993,48995). Abdominal pain has been reported in a trial of the eucalyptus constituent eucalyptol for inflammatory bowel disease (IBD) (48936).
Immunologic
...A case of IgE-mediated exacerbation of asthma and rhinitis symptoms has been reported in a patient who consumed eucalyptus.
Similar worsening of symptoms occurred when the patient inhaled eucalyptus pollen (48957).
Occupational exposure to eucalyptus may cause allergic dermatitis (98497).
Neurologic/CNS
...Orally, eucalyptus oil can cause central nervous system depression, coma, and status epilepticus (12867,48946,48983).
Topically, orally, and by inhalation, eucalyptus oil has been associated with seizures. A systematic review describes the characteristics of 49 children and 61 adults with seizures associated with various routes of administration. Patients with no seizure history were classified as a eucalyptus oil-induced seizure (EOIS), while patients with a history of seizure or susceptibility to seizure were defined as a eucalyptus oil-provoked seizure (EOPS). In EOIS cases, topical use was reported in 74%, inhalation in 22.5%, and ingestion in 3.5%; for EOPS cases, topical use was reported in 79%, inhalation in 16%, and ingestion in 5%. Generalized tonic-clonic seizures are the most prominent type of seizure in EOIS cases (96%). Among EOPS patients, 37% had focal onset motor seizures with impaired awareness, 24% had focal onset aware motor seizures, 13% had focal to bilateral tonic-clonic seizures, and 26% had generalized onset tonic-clonic seizures (107494). One prospective observational study that was included in this systematic review provided additional details on eucalyptus-induced seizures. This study included 18 reports of EOIS and 28 reports of EOPS in adults and children after topical or inhaled use of eucalyptus oil, either alone or in combination with camphor. The time to seizure onset was 0.5-48 hours after topical application, 2-30 minutes after inhalation, and 0.5-6 hours after ingestion. (105028).
One prospective observational study and one case series have described 20 case reports of seizures occurring in children after ingestion of eucalyptus oil. Most of these seizures are generalized tonic-clonic in nature, occur 15-30 minutes after exposure, and do not reoccur following the discontinuation of eucalyptus oil. Seizures have been reported with both overdoses and therapeutic doses (107493,107495) and include cases of both EOIS and EOPS (107495). Additionally, children appear more likely to require intensive care and mechanical ventilation when compared with adult cases (107494).
A case of fever and headache has been reported in a patient who routinely applied a teaspoon of gel containing eucalyptus extract in his throat or nose to treat sore throat or rhinitis (48946).