Camphor 10% • Menthol 10% • Methyl Salicylate 10%. Other Ingredients: Capsicum Oleoresine, Petroleum Gel, Lanoline Anhydre, Paraffin.
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 Formule D 2. 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 Formule D 2. 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 peppermint oil is used orally, topically, or rectally in medicinal doses. Peppermint oil has been safely used in multiple clinical trials (3801,3804,6190,6740,6741,10075,12009,13413,14467,17681)(17682,68522,96344,96360,96361,96362,96363,96364,96365,99493).
POSSIBLY SAFE ...when peppermint leaf is used orally and appropriately, short-term. There is some clinical research showing that peppermint leaf can be used safely for up to 8 weeks (12724,13413). The long-term safety of peppermint leaf in medicinal doses is unknown. ...when peppermint oil is used by inhalation as aromatherapy (7107). There is insufficient reliable information available about the safety of using intranasal peppermint oil.
CHILDREN: POSSIBLY SAFE
when used orally for medicinal purposes.
Enteric-coated peppermint oil capsules have been used with apparent safety under medical supervision in children 8 years of age and older (4469).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (96361).
There is insufficient information available about the safety of using peppermint in medicinal amounts during pregnancy or lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Formule D 2. 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.
 Details
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Theoretically, peppermint oil might increase the levels and adverse effects of cyclosporine.
Details
In animal research, peppermint oil inhibits cyclosporine metabolism and increases cyclosporine levels. Inhibition of cytochrome P450 3A4 (CYP3A4) may be partially responsible for this interaction (11784). An interaction between peppermint oil and cyclosporine has not been reported in humans.
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Theoretically, peppermint might increase the levels of CYP1A2 substrates.
Details
In vitro and animal research shows that peppermint oil and peppermint leaf inhibit CYP1A2 (12479,12734). However, in clinical research, peppermint tea did not significantly affect the metabolism of caffeine, a CYP1A2 substrate. It is possible that the 6-day duration of treatment may have been too short to identify a difference (96359).
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Theoretically, peppermint might increase the levels of CYP2C19 substrates.
Details
In vitro research shows that peppermint oil inhibits CYP2C19 (12479). So far, this interaction has not been reported in humans.
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Theoretically, peppermint might increase the levels of CYP2C9 substrates.
Details
In vitro research shows that peppermint oil inhibits CYP2C9 (12479). So far, this interaction has not been reported in humans.
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Theoretically, peppermint might increase the levels of CYP3A4 substrates.
Details
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Below is general information about the adverse effects of the known ingredients contained in the product Formule D 2. 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, topically, or rectally, peppermint oil is generally well tolerated.
Inhaled,
peppermint oil seems to be well tolerated. Intranasally, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted. Orally, peppermint leaf seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, anal burning, belching, diarrhea, dry mouth, heartburn, nausea, and vomiting.
Topically: Burning, dermatitis, irritation, and redness.
Dermatologic
...Topically, peppermint oil can cause skin irritation, burning, erythema, and contact dermatitis (3802,11781,31528,43338,68473,68457,68509,96361,96362).
Also, a case of severe mucosal injury has been reported for a patient who misused an undiluted over the counter mouthwash that contained peppermint and arnica oil in 70% alcohol (19106).
In large amounts, peppermint oil may cause chemical burns when used topically or orally. A case of multiple burns in the oral cavity and pharynx, along with edema of the lips, tongue, uvula, and soft palate, has been reported for a 49-year-old female who ingested 40 drops of pure peppermint oil. Following treatment with intravenous steroids and antibiotics, the patient's symptoms resolved over the course of 2 weeks (68432). Also, a case of chemical burns on the skin and skin necrosis has been reported for a 35-year-old male who spilled undiluted peppermint oil on a previous skin graft (68572). Oral peppermint oil has also been associated with burning mouth syndrome and chronic mouth ulceration in people with contact sensitivity to peppermint (6743). Also, excessive consumption of mint candies containing peppermint oil has been linked to cases of stomatitis (13114).
Gastrointestinal ...Orally, peppermint oil can cause heartburn, nausea and vomiting, anal or perianal burning, abdominal pain, belching, dry mouth, diarrhea, and increased appetite (3803,6740,6741,6742,10075,11779,11789,17682,68497,68514)(68532,68544,96344,96360,102602,104219,107955). Enteric-coated capsules might help to reduce the incidence of heartburn (3802,4469,6740,11777). However, in one clinical study, a specific enteric-coated formulation of peppermint oil (Pepogest; Nature's Way) taken as 180 mg three times daily was associated with a higher rate of adverse effects when compared with placebo (48% versus 31%, respectively). Specifically, of the patients consuming this product, 11% experienced belching and 26% experienced heartburn, compared to 2% and 12%, respectively, in the placebo group (107955). A meta-analysis of eight small clinical studies in patients with irritable bowel syndrome shows that taking enteric-coated formulations of peppermint oil increases the risk of gastroesophageal reflux symptoms by 67% when compared with a control group (109980). Enteric-coated capsules can also cause anal burning in people with reduced bowel transit time (11782,11789).
Genitourinary ...Orally, a sensitive urethra has been reported rarely (102602).
Hepatic ...One case of hepatocellular liver injury has been reported following the oral use of peppermint. Symptoms included elevated liver enzymes, fatigue, jaundice, dark urine, and signs of hypersensitivity. Details on the dosage and type of peppermint consumed were unavailable (96358).
Immunologic ...One case of IgE-mediated anaphylaxis, characterized by sudden onset of lip and tongue swelling, tightness of throat, and shortness of breath, has been reported in a 69-year-old male who consumed peppermint candy (89479). An allergic reaction after use of peppermint oil in combination with caraway oil has been reported in a patient with a history of bronchial asthma (96344). It is not clear if this reaction occurred in response to the peppermint or caraway components.
Neurologic/CNS ...Orally, headache has been reported rarely (102602).
Ocular/Otic ...Orally, peppermint has been reported to cause blurry vision (3803).
