Safety and Efficacy Data of the Constituent Ingredients of Motion Medicine

 

This investigation into the positive effects  of Motion Medicine is backed be the over 100 clinical studies referenced and listed here-in.

Prepared under contract by
Dustin L Johnson PhD (Medical Science)


Contact information:

Dustin L Johnson, PhD
dustjohn@gmail.com


Motion Medicine

Motion Medicine (MM) is a blend of ingredients recommended for topical application to areas of body soreness for the relief of pain due to inflammation, muscle strains and joint arthritis. Within the cream are known anti-inflammatory compounds (methyl salicylate and methylsulfonylmethane), analgesics (menthol, camphor, thymol, and lavender oil) and circulation enhancers, as well as ingredients that may facilitate tissue repair (glucosamine, condroitin, vitamin E, grape seed and sea cucumber extract). Specially formulated with skin permeants (eucalyptus oil and polysorbate 20) and hydrating ingredients (glycerol), MM is a very safe and highly efficacious topical therapy cream.

Health Claims: - for the management of pain and inflammation due to muscle strains and osteoarthritis

- may facilitate healing of damaged muscle and cartilage tissue

Motion Medicine is appropriate for self-care because it relieves pain and inflammation associated with common ailments including muscle aches and strains and osteoarthritis, and may promote and improve the health of users.

The route of administration of MM is strictly limited to external application to areas of body soreness. Motion Medicine has a restricted dose of 10 grams per day and should not be used on children or if pregnant or breast-feeding.

Motion Medicine has been sold in Canada for over 10 years under the trade names Embracecare Treatment Cream and Proflex. It has been distributed to participants at amateur golf tournaments and to chiropractors across the country; therefore it is estimated that hundreds, if not thousands, of Canadians have used this cream for self-care treatment of inflammation and pain associated with muscle strains and osteoarthritis. To date there have not been any reported adverse events associated with self-care use of Motion Medicine.


Safety: Evidence for Low Systemic Exposure of Topically Applied Motion Medicine

In their undiluted form (i.e. concentrations approximating 100%), some of the ingredients found within Motion Medicine are of toxicological concern. These ingredients include camphor, methyl salicylate and thymol. However, when used diluted within MM, these compounds are no longer considered harmful. Other commonly used over-the-counter topical analgesics tend to have higher concentrations of these ingredients, suggesting MM is safer than other creams. A study was recently conducted that measured the systemic exposure to camphor, methyl salicylate and menthol through topical application of dermal patches; it was found that when a total of 300 mg menthol, 375 mg camphor and 600 mg methyl salicylate were applied to the skin for 8 hours, the resulting plasma concentrations of each compound reached only up to 40 nanograms/mL (representing less than 1/1000th of the amount of each compound originally applied to the skin) (Martin et al. 2004). In addition to low systemic exposure through dermal patches containing menthol/camphor/methyl salicylate, this research also revealed that removal of these compounds occurs relatively quickly within the human body (within hours of topical application), suggesting that camphor, methyl salicylate and menthol are unlikely to accumulate within the body with daily use of MM. Together the results suggest that daily topical application of MM is safe and is not likely to lead to any major adverse events.


Efficacy: Evidence for Pain Reduction Due to Osteoarthritis

A double-blind randomized control clinical study has been conducted to assess the level of pain reduction due to knee osteoarthritis after topical application of a cream containing 0.3% glucosamine sulfate, 0.72% condroitin sulfate, 1.4% shark cartilage (of which 10-30% is condroitin sulfate), 3.2 % camphor, 0.9% peppermint oil (which has a high menthol content), emulsifiers, and skin emollients (Cohen et al. 2003). The placebo cream contained less than 0.9% peppermint oil, emulsifiers, emollients as well as stearic acid and glycerol stearate. Subjects were told to generously apply the cream to their painful knees, and to repeat cream application as necessary (it was estimated that on average 30 mg glucosamine, 78 mg chondroitin and 320 mg camphor were applied each day). The study lasted eight weeks and fifty nine subjects (of 63) completed the study. Reduction of pain associated with knee osteoarthritis was statistically significant for the group receiving cream containing glucosamine/chondroitin/camphor (Cohen et al. 2003). Adverse events were minimal (above the placebo group, 1 subject reported fatigue, 1 subject reported nausea, 1 subject withdrew due to blurred vision while another withdrew due to gall stones), indicating that liberal use of this cream over a period of eight weeks was safe. The results suggest that daily application of a cream containing a glucosamine-chondroitin-camphor combination can significantly reduce the pain associated with knee osteoarthritis (Cohen et al. 2003).


Caveats

Motion Medicine as a formulation has not been studied in vitro or in vivo. Thus any safety and efficacy data must be extrapolated from studies using similar creams containing the ingredients found within MM. Invariably these compounds are present in different ratios and may occur in the presence of compounds not found within MM and/or in the absence of compounds found within MM.

The following is a list of ingredients found within MM (the concentration of each compound within the cream is given) followed by scientific evidence of the safety and efficacy of each ingredient. Where available, a significant attempt has been made to focus on studies employing external rather than internal exposure to the ingredients, and to highlight studies carried out on humans rather than lab animals or in in vitro cell culture systems.


Dimethyl Sulfone (Methylsulfonylmethane or MSM)

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 500 milligram dose of MSM (7.14 milligrams/kg).

Safety: topical MSM

- a cream containing methylsulfonylmethane (as well as amino acids, vitamins, and antioxidants) was applied daily to the skin of a man with ichthyoses (a genetic skin disorder) over the course of four weeks and no adverse reactions were reported (Fleck 2006)

- treatment of interstitial cystitis with MSM revealed low side-effects (Childs 1994)

Efficacy: topical MSM

- MSM has anti-inflammatory activity

- an in vitro study determined that MSM reduces neutrophil by-products associated with causing inflammation (Beilke et al. 1987)

Efficacy: oral MSM

- MSM improves symptoms of pain and physical functioning associated with knee osteoarthritis (Kim et al. 2006)

• 3 grams of MSM was taken orally twice a day for 12 weeks by 25 men and women aged 40-76; MSM was shown to relieve pain associated with osteoarthritis

• no adverse events were reported above those reported within the placebo group

- reduces inflammation and pain associated with osteoarthritis (Usha and Naidu 2004)

• this randomized double-blind placebo-controlled study indicated that 1500 mg/day of MSM (in combination with glucosamine sulfate) taken orally relieved symptoms of knee osteoarthritis (analgesic and anti-inflammatory effect) and was well tolerated

Safety: oral MSM

- a study was conducted to evaluate the efficacy of MSM in the reduction of symptoms of seasonal allergic rhinitis, possible adverse reactions to MSM supplementation were monitored and recorded and found to be minimal (Barrager et al. 2002)

• 2.6 grams of MSM was taken orally once a day for 30 days by 15 males and 35 females between the ages of 21 and 60; a subset of subjects further took 5.2 grams for an additional 14 days, few side effects were observed

Contraindications

- the published trials data of oral MSM use did not report any serious side-effects

- there are no peer-reviewed studies on the effects of long-term use in humans


Material Safety Data Sheet

Toxicity Studies

- low oral toxicity: LD50 (dose required to kill 50% of the animals) is greater than 17 g/kg in rats

- In rats, 2 g/kg (single gavage) did not cause adverse events, and long term administration (1.5 g/kg for 90 days) did not cause adverse events (Horvath et al. 2002)

- the no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity in rats is 1 gram/kg/day (Magnuson et al. 2007b)

Notes

- a medical doctor with the Oregon Health and Science University has used MSM to treat over 18,000 patients with a variety of ailments, including topical application (taken from http://en.wikipedia.org/wiki/Dimethylsulfone on Jan. 22, 2008)

- recommended daily dose for dietary supplement is 1-6 grams/day


Camphor

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 500 milligram dose of camphor (7.14 milligrams/kg).

Safety: topical camphor

Review of topical camphor poisonings of children in the U.S. from 1990-2003 (Manoguerra et al. 2006)

- 15 month old boy crawled through spilled camphor spirits and developed ataxia and generalized convulsions

- 2 month old girl developed elevated serum transaminase (indicates liver dysfunction) following application to her chest and neck of Vicks VapoRub (4.8% camphor) 3 times a day for 5 days

- 25 month old boy developed delirium, visual hallucinations and urinary incontinence after his chest was “soaked in” more than 1 ounce of camphorated oil for 80 hours (6.4 grams of camphor)

- 9 month old girl with 20% body surface area scald burn was treated with a dressing containing 9.6% camphor for 24 hours and developed severe toxicity, including convulsions; estimated exposure to 15 grams camphor

Review of topical camphor adult cases in the U.S. from 1990-2003 (Manoguerra et al. 2006)

- a 72-year-old woman developed granulomatous hepatitis (indicative of a systemic disorder) following dermal application of five containers of Vicks VapoRub Ointment over a 5-year period; following discontinuation of use of the product, the problem appeared to be resolved

- dermal absorption of camphor was low from medicated patches containing 46.8 mg camphor (in conjunction with 37.44 mg menthol and 74.88 mg methyl salicylate) (Martin et al. 2004)

Efficacy: topical camphor

- topical application of glucosamine sulfate (0.3%) with chondroitin sulfate (0.78%) and camphor (3.2%) is effective in relieving the pain associated with knee osteoarthritis (Cohen et al. 2003)

Safety: non-topical camphor

- oral exposure of children ages 14 months to 5 years old to 0.7-1.5 grams of camphor resulted in death or potentially fatal symptoms (respiratory depression, seizures) (Love et al. 2004)

- 80 postpartum women were injected intramuscularly with 195 milligrams camphor on day one followed by daily injections of 97 milligrams over 3 days (total 486 mg camphor). One patient developed nausea and vomiting, the others did not report any adverse events (Manoguerra et al. 2006)

Contraindications

- camphor may aggravate kidney, liver, and heart disorders

- people with epilepsy should avoid products containing camphor

- children should avoid products containing camphor

Material Safety Data Sheet (100% Camphor)

Safety/Toxicity Studies

- oral LD50 in a mouse is 1.3 grams/kg

- camphor may be toxic to skin, eyes, central nervous system

- may affect genetic material based on animal data; passes through the placental barrier in humans

- causes skin/eye irritation; may cause epileptic seizures

- ingestion may irritate the G.I. system, and affect behaviour (motor activity, rigidity)

Notes

- the US FDA in 1980 set a limit of 11% camphor in consumer products due to the fact that ingestion of large quantities may cause seizures, confusion, irritability, and neuromuscular hyperactivity


Menthol

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 500 milligram dose of menthol (7.14 milligrams/kg).

Safety: topical menthol

- the FDA considers menthol a safe over-the-counter topical agent (Patel et al. 2007)

- creams with up to 16% menthol are considered to have a high margin of safety (regarding two different menthol containing products, 1 in 310,000 and 1 in 950,000 customers filed a complaint with the FDA) (Patel et al. 2007)

Efficacy: topical menthol

- the exact mechanism by which menthol produces analgesia is unresolved (Patel et al. 2007); pain relief was postulated to be associated with the ability of menthol to stimulate and/or inhibit the skin receptors TRPM8 and TRPA1, respectively (Macpherson et al. 2006); analgesic activity may also be related to desensitization of nociceptive C fibers (Cliff and Green 1994)

- determined that menthol has a strong dose-dependent anesthetic effect using in vivo rabbit conjuctival reflex test and in vitro rat phrenic nerve conductance tests (Galeotti et al. 2001)

- menthol blocked in vitro resting and inactivated voltage gated sodium channels obtained from human skeletal muscle, thus providing a molecular basis for an antinociceptive and anesthetic effect (Haeseler et al 2002)

- through competitive inhibition in mouse models of analgesia it was shown that menthol exerts anesthetic effects through selective activation of kappa-opioid receptors (Galeotti et al. 2002)

- cited as a counterirritant for relieving musculoskeletal pain (Eccles 1994)

- forearms of subjects were rubbed with 100 mg menthol (in ethanol/water) or just ethanol/water and tested for sensations. Menthol created a cooling effect, and altered the permeability of the stratum corneum to water (Yosipovitch et al. 1996)

- serves as an agonist of the cold sensitive skin receptor TRPM8, thus producing a cooling sensation (McKemy et al. 2002)

- in concentrations less than 1%, menthol depresses cutaneous sensory receptors; between 1.25 - 16% menthol acts as a counter-irritant through stimulation of sensory receptors (Patel et al. 2007)

- menthol breaks hydrogen bonds between ceramides, and therefore increases the hydrophilicity of the stratum corneum bilayer which may aide in delivery of hydrophilic molecules through the skin (Panchagnula et al. 2004)

- 5% menthol enhances drug delivery across human cadaver skin (Narishetty and Panchagnula 2005)

- in vitro pretreatment of rat skin with 10% menthol enhanced drug penetration (Liu et al. 2006)

- facilitates drug permeation (Williams and Barry 2004)

- produces statistically significant local vasodilation (Namer et al. 2005)

- enhances blood flow

• a placebo-controlled study of topical application of Eucalyptamint (containing eucalyptus oil, 16% menthol and lanolin) was carried out on 10 subjects. The cream was applied to one forearm of each individual, and placebo applied to the other. Statistically significant increases in blood flow to the areas of application were observed (Hong and Shellock 1991)
Material Safety Data Sheet (100% menthol)

Safety/Toxicity Studies

- acute dermal toxicity in the rabbit: LD50 = 5 grams/kg

- oral toxicity in the rat: LD50 2.9 grams/kg

- oral toxicity in the mouse: LD50 3.1 grams/kg

- rats given menthol at 200 mg/kg/day for 28 days had increased liver weights and vacuolization of hepatocytes (Thorup et al. 1983)

Notes

- menthol is included in many consumer products including OTC creams, lozenges and mouthwashes


Wintergreen Oil (Gaultheria procumbens/Methyl Salicylate)

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 100 milligram dose of methyl salicylate (1.43 milligrams/kg).

Safety: topical methyl salicylate

- methyl salicylate is considered safe for inclusion in cosmetic formulations (Cosmetic Ingredient Review Expert Panel 2003)

- Bengay (18.3% methyl salicylate and 16% menthol) applied to a 62 year old man’s forearms and legs combined with periodic heating of the area with a heat pad resulted in local necrosis after 1 day of use (Heng 1987)

- tinnitus (ringing noise), diplopia (double vision), shortness of breath and mixed metabolic acidosis and respiratory alkalosis was evident for a 62 year old man who had used a methyl salicylate ointment for several weeks on his thigh, twice daily (Morra et al.1996)

- frequent topical application of a 15% methyl salicylate cream (Bengay) resulted in the death of a 17 year old female (http://www.associatedcontent.com/article/283504/death_by_bengay_toxic_do... accessed Jan. 22, 2008)

Efficacy: topical methyl salicylate

- salicylate exerts anti-inflammatory activity by inhibiting cyclooxygenase and protects tissue from injury (Wu 2003)

- using cutaneous microdialysis on human subjects it was determined that methyl salicylate directly penetrates skin and underlying tissue (Cross et al. 1998)

- using an in vitro skin penetration model and an in vivo rat model it was shown that topical methyl salicylate can achieve rapid and prolonged therapeutic concentrations in superficial muscle, and that it enhances local blood flow in cutaneous vessels (Cross et al. 1999)

Contraindications

- pregnancy

- children

- people using anti-coagulant therapy (i.e. warfarin)

Material Safety Data Sheet (100% methyl salicylate)

Safety/Toxicity Studies

- prolonged contact with skin may cause dermatitis

- for dermal exposure, the LD50 in rats is 2g/kg; subchronic dermal exposure to undiluted methyl salicylate may lead to kidney damage; dermal exposure to methyl salicylate may lead to reproductive and developmental toxicity, but is considered safe for use in cosmetic formulations (Cosmetic Ingredient Review Expert Panel 2003)

- oral LD50 in the rat is 887 mg/kg

- lowest published lethal oral dose in humans - woman: 355 mg/kg; man: 101 mg/kg; child 228 mg/kg

- a teaspoon or less of oil of wintergreen has been implicated in several deaths of children under the age of 6 (Davis 2007)

- mutagenic for bacteria and/or yeast; therefore may cause adverse reproductive effects and birth defects (teratogenic) (passes the placental barrier and concentrates in the fetus)

- may be toxic to kidneys, liver, heart, central nervous system

Notes

- oil of wintergreen is 98% methyl salicylate

- the rate and extent of absorption through the skin may be dependent on area of the body as determined on equine skin (Mills and Cross 2007)


Glucosamine Sulfate

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 500 milligram dose of glucosamine sulfate (7.14 milligrams/kg).

Safety: topical glucosamine

- clinical trials have consistently reported that consuming glucosamine (grams/day) is safe; Cohen et al. (2003) did not observe any significant adverse events associated with topical application of a cream containing 0.3% glucosamine sulfate

Efficacy: topical glucosamine

- topical application of glucosamine sulfate (0.3%) with chondroitin sulfate (0.78%) and camphor (3.2%) is effective in relieving the pain associated with knee osteoarthritis (Cohen et al. 2003)

Efficacy: oral glucosamine

- reduces inflammation and pain associated with osteoarthritis (Usha and Naidu, 2004)

• randomized, double-blind placebo-controlled study indicated that oral consumption of 1500 milligrams/day of glucosamine (in combination with MSM) relieved symptoms of knee osteoarthritis (had an analgesic and anti-inflammatory effect) and was well tolerated

Material Safety Data Sheet (100% glucosamine sulfate)

Safety/Toxicity Studies

- repeated or prolonged exposure is not known to aggravate medical conditions

Notes

- glucosamine is extensively used in veterinary medicine (Nolen 2002)

- large clinical trials indicate oral glucosamine reduces progression of knee osteoarthritis and prevents joint space narrowing (Reginster et al. 2001; Pavelka et al. 2002)


Sodium Chondroitin Sulfate

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 50 milligram dose of sodium chondroitin sulfate (0.71 milligrams/kg).

Safety: topical chondroitin sulfate

- clinical trials have consistently reported that consuming chondroitin sulfate (grams/day) is safe (Mazieres et al. 2007; Mazieres et al. 2001); Cohen et al. (2003) did not observe any significant adverse events associated with topical application of a cream containing 0.78% chondroitin sulfate

Efficacy: topical chondroitin

- topical application of glucosamine sulfate (0.3%) with chondroitin sulfate (0.78%) and camphor (3.2%) is effective in relieving the pain associated with knee osteoarthritis (Cohen et al. 2003)

- chondroitin sulfate injected into the joints of rabbits resulted in enhanced cartilage repair (Hui et al. 2007)

- chondroitin sulfate accelerated wound healing in rabbit sinuses (Gilbert et al. 2004)

Material Safety Data Sheet (100% chondroitin sulfate)

Safety/Toxicity Studies

- repeated or prolonged exposure is not known to aggravate medical conditions

- oral LD50 for the mouse is greater than 10 grams/kg

Notes

- chondroitin in combination with glucosamine may be an effective treatment in patients with moderate to severe knee pain (Distler and Anguelouch 2006)

- enhances the pain relieving action of glucosamine in osteoarthritis (Das and Hammad 2000; Deal and Moskowitz 1999)

- evidence suggests chondroitin sulfate and glucosamine sulfate interfere with the progression of osteoarthritis (Bruyere and Reginster 2007)


Eucalyptus Leaf Oil (Eucalyptus globulus/1, 8-cineole)

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 100 milligram dose of eucalyptol (1.43 milligrams/kg).

Safety: topical eucalyptus oil

- widespread application of eucalyptus oil to a 6 year old resulted in slurred speech, ataxia (lack of muscle co-ordination) and muscle weakness that progressed to unconsciousness (Darben et al. 1998)

- a 2-year old boy rubbed with eucalyptus oil presented to hospital with fever and seizure-like motor activity (Dreisinger et al. 2006)

- there are no known cases of death caused by topical application of eucalyptus oil (Dreisinger et al. 2006)

Efficacy: topical eucalyptus oil

- eucalyptus oil is a well-known skin penetrant: 1, 8-cineole (5%) enhances drug delivery across human cadaver skin (Narishetty and Panchagnula 2005)

- in vitro human skin exhibited increased lipid disruption and permeability to topically applied drug when it was formulated with 1, 8-cineole (Yamane et al. 1995)

- shown to effectively enhance penetration of 5-fluorouracil in in vivo human skin studies (Williams and Barry 2004)

Safety: oral eucalyptus oil

- only minor side effects were reported in two patients of 76 after ingesting 600 milligrams of eucalyptus oil daily for 7 days (Kehrl et al. 2004)

Efficacy: oral eucalyptus oil

- exhibits anti-inflammatory activity in multiple rodent models of inflammation (Yuan et al. 2006; Santos and Rao 2000)

- exhibits antinociceptive (analgesic) properties similar to morphine in an animal model (Liapi et al. 2007)

Contraindications

- do not use on children

Material Safety Data Sheet (100% eucalyptus oil)

Safety/Toxicity Studies

- oral LD50 in the rat is 2.5 grams/kg

- eucalyptus oil is toxic to the lungs

- hazardous in case of skin contact, may cause itching, scaling, reddening or blistering

Notes

- found in mouthwashes and cough suppressants

 


 

Grape Seed Oil (Vitis vinifera)

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 100 milligram dose of grape seed oil (1.43 milligrams/kg).

Safety: grape seed extract (GSE)

- extensive acute and chronic safety studies for oral and dermal GSE has been conducted on animals and shown to be safe (Ray et al. 2001)

- grape seed extract was shown to be non-mutagenic in a mouse in vivo study (Erexson 2003)

- procyanidin B-2 (a component of GSE) was thoroughly studied in mutagenic and ocular irritation assays and found to be safe for topical application (Takahashi et al. 1999)

- proanthocyanidin extract has been documented as safe for consumption at 1.4 grams/kg per day (Yamakoshi et al 2002)

Efficacy: topical grape seed extract

- grape seed extract has the ability to heal damaged tissue

• two dermal wounds were inflicted on the back of mice and allowed to heal. Grape seed extract was then applied to one wound and this resulted in a hyperproliferative epithelial region, higher cell density, enhanced deposition of connective tissue and improved histological architecture (Khanna et al. 2002)

- procyanidins from grape seeds can protect against carcinogen-induced oxidative cellular and genotoxic damage in vitro and in vivo (Lu et al. 2004; Rho and Kim 2006)

Efficacy: intraperitoneal/oral grape seed extract

- grape seed oil (administered via intraperitoneal injection) was shown to be anti-inflammatory in both a mouse (ear) and rat (paw) model of inflammation (Li et al. 2001)

- grape seed extract is a scavenger of oxygen free radicals, has anti-lipid peroxidation activity, and inhibits the formation of inflammatory cytokines (Bagchi et al. 2000)

Contraindications

None.

Material Safety Data Sheet (100% grape seed oil)

Safety/Toxicity Studies

- the LD50 for dermal application of grape seed extract to rats is greater than 2 grams/kg (Ray et al. 2001)

- repeated or prolonged exposure is not known to aggravate medical conditions

- repeated contact with skin may cause allergic dermatitis

- a lethal dose of procyanidin B-2 (by subcutaneous injection in rats) is greater than 2 grams/kg (Takahashi et al. 1999)

Notes

- contains antioxidants, linoleic acid (omega-6), vitamin E, C and beta-carotene

 


 

Lavender Oil (Lavandula angustifolia)

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 50 milligram dose of lavender oil (0.71 milligrams/kg).

Safety: topical lavender oil

- prolonged or repeated skin contact may cause allergic dermatitis (reviewed in Cavanagh and Wilkinson 2002)

Efficacy: topical lavender oil

- topical application of an ethanol extract of Lavandual multifida exhibited dose-dependent anti-inflammatory activity in in vivo mouse models of inflammation (Sosa et al. 2005)

- the major components of lavender oil, linalool and linalyl acetate, are rapidly absorbed through the skin after topical application and have local anesthetic activity (reviewed in Cavanagh and Wilkinson 2002)

- lavender oil may promote wound healing (Cavanagh and Wilkinson 2002; Woollard et al. 2007)

Contraindications

- 1st trimester of pregnancy

- children (may cause gynecomastia (enlargement of breast tissue))

Material Safety Data Sheet (100% lavender oil)

Safety/Toxicity Studies

- dermal LD50 in rabbits is 5 grams/kg

- oral LD50 in rats is 4.25 grams/kg

- repeated or prolonged exposure is not known to aggravate medical conditions

Notes

- present in shampoos and skin lotions

- other constituent components of lavender oil include 1, 8-cineole, beta-ocimene, terpinen-4-ol and camphor (Cavanagh and Wilkinson 2002)

 


 

Alpha-Tocopherol Acetate (Vitamin E)

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 100 milligram dose of tocopherol acetate (1.43 milligrams/kg).

Safety: topical tocopherol acetate

- tocopherol acetate is safe for topical use (Thiele and Ekanayake-Mudiyanselage 2007)

Efficacy: topical tocopherol acetate

- topical application of tocopherol acetate to hairless mouse skin upregulated the anti-oxidant activity within the dermis and epidermis, resulting in less tissue damage in response to epidermal lipid hydroperoxides induced by exposure to UV light (Lopez-Torres et al. 1998)

- alpha-tocopherol at concentrations less than 0.2% is able to significantly increase vitamin E levels in the stratum corneum of human skin and protect against lipid peroxidation in vivo (Ekanayake-Mudiyanselage et al. 2005); therefore it was suggested that skin care products containing between 0.1 - 1% tocopherol acetate will likely enhance anti-oxidant protection of the skin

Contraindications

None.

Material Safety Data Sheet (100% tocopherol acetate)

Safety/Toxicity Studies

- repeated or prolonged exposure is not known to aggravate medical conditions

Notes

- often used in skin creams; may protect the skin against ultraviolet rays (Thiele and Ekanayake-Mudiyanselage 2007)

 


 

Thymol

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 50 milligram dose of thymol (0.71 milligrams/kg).

Safety: topical thymol

- considered safe for use in cosmetic formulations at 0.5% (Andersen 2006)

Efficacy: topical thymol

- antinociceptive and anesthetic effects have been supported by evidence showing that thymol blocks resting and inactivated voltage gated sodium channels obtained from human skeletal muscle (Haeseler et al. 2002)

- thymol was suggested to be as potent as lidocaine (Haeseler et al. 2002)

Contraindications

- kidney disease

- liver disease

Material Safety Data Sheet (100% thymol)

Safety/Toxicity Studies

- thymol is toxic to mucous membranes, and may be toxic to kidneys, liver, and the central nervous system

- may cause adverse reproductive effects based on animal test data and may affect genetic material

- causes skin irritation that may vary from mild irritation to severe destruction of tissue depending on the intensity and duration of the exposure

- oral LD50 in rats is 980 milligrams/kg; in mice is 640 milligrams/kg; and in guinea pigs is 880 milligrams/kg

Notes

- thymol is a structural homolog of menthol

 


 

Stearyl Alcohol

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 400 milligram dose of stearyl alcohol (5.7 milligrams/kg).

Safety: topical stearyl alcohol

- may cause contact dermatitis (Meijer et al. 2007; Yesudian and King 2001)

Efficacy: topical stearyl alcohol

- used as a thickening agent/skin softener and is commonly found in perfumes, cosmetics, shampoos and hair conditioners (taken fromhttp://en.wikipedia.org/wiki/Stearyl_alcohol on Jan. 22, 2008)

Material Safety Data Sheet (100% stearyl alcohol)

Safety/Toxicity Studies

- oral LD50 in the rat is 20 grams/kg

- repeated or prolonged exposure is not known to aggravate medical conditions

Notes

- found to be non-comedogenic (non-pore clogging) using a rabbit model (Nguyen et al. 2007)

 


 

Glycerin (Glycerol)

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 400 milligram dose of glycerol (5.7 milligrams/kg).

Safety: topical glycerol

- a common ingredient in cough syrups, expectorants, toothpaste, mouthwashes, skin care products, shaving cream, hair care products and soaps (taken from
http://en.wikipedia.org/wiki/Glycerol Jan. 22, 2008)

Efficacy: topical glycerol

- abolishes skin irritation and prevents dehydration of the skin (Gloor and Gehring 2001; Gloor 2004)

Contraindications

- kidney disease

- pregnancy

Material Safety Data Sheet (100% glycerol)

Safety/Toxicity Studies

- dermal toxicity (LD50) in rabbits is 10 grams/kg

- oral toxicity (LD50) in rats is 12.6 grams/kg; in mice 4 grams/kg

- glycerol may be toxic to kidneys

- may affect genetic material

- may cause adverse reproductive effects based on animal data

 


 

Polysorbate 20

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 100 milligram dose of polysorbate 20 (1.43 milligrams/kg).

Safety: topical polysorbate 20

- safe for use in cosmetic formulations (Lanigan and Yamarik 2001)

Efficacy: topical polysorbate 20

- used in formulating biotherapeutics (Kerwin 2007)

Contraindications

- pregnancy

- do not place on skin burns

Material Safety Data Sheet (100% polysorbate 20)

Safety/Toxicity Studies

- oral LD50 in the mouse is greater than 33 grams/kg; intravenous LD50 is 1.4 grams/kg

- chronic exposure may result in development abnormalities in the musculoskeletal system

Notes

- used to stabilize a purified protein derivative solution used in skin testing for tuberculosis exposure (taken fromhttp://en.wikipedia.org/wiki/Tween_20 on Jan. 22, 2008)

 


 

Urea

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 100 milligram dose of urea (1.43 milligrams/kg).

Safety: topical urea

- a topical cream containing 40% urea was well-tolerated over a period of 2-3 weeks with daily application to a fungal skin infection (Elewski et al. 2004)

Efficacy: topical urea

- hydrating agent and modest penetration enhancer (Williams and Barry 2004)

Contraindications

- pregnancy

- cardiovascular disease

Material Safety Data Sheet (100% urea)

Safety/Toxicity Studies

- oral LD50 in the rat is 8.5 grams/kg

- oral LD50 in the mouse is 11 grams/kg

- mutagenic for mammalian somatic cells

- urea may be toxic to blood, cardiovascular system

- may cause reproductive effects (fetotoxicity) and mutagenicity based on animal studies

- passes through the placental barrier in humans and is present in breast milk

Notes

- urea is the detoxified metabolite of ammonia in the human body and is normally present at levels between 2.5 - 7.5 mmol/liter (assuming 5 litres of blood in the average human, this translates to 500 - 2000 milligrams of urea normally present in the blood)

- commonly found in hair conditioners, facial cleansers, bath oils and lotions, in tooth whitening products, in creams to soften the skin and promote rehydration (taken from http://en.wikipedia.org/wiki/Urea on Jan. 22, 2008)

 


 

Sea Cucumber

A 70 kg person applying 10 grams of Motion Medicine would topically receive a 200 milligram dose of sea cucumber extract (2.86 milligrams/kg).

Safety: topical sea cucumber extract (SCE)

- daily exposure of SCE to gingival tissue over the course of 3 months was safe (Taiyeb-Ali et al. 2003)

Efficacy: topical sea cucumber extract

- SCE has the ability to heal gingival tissue

• A randomized double-blind study of 28 patients with chronic gingivitis were separated into two groups of 14. One group brushed twice daily with toothpaste containing SCE, and the other without SCE. In terms of plaque index, gingival index, papilla bleeding index and probing pocket depth, statistically significant improvements were noted in the test group after 1-3 months of use (Taiyeb-Ali et al. 2003)

- SCE contains fatty acids (i.e. EPA) involved in tissue repair (Fredalina et al. 1999)

- SCE has high anti-oxidant activity (Zhong et al. 2007)

Safety: oral sea cucumber extract

- sea cucumber extract as an oral supplement taken daily for up to six months had no adverse effects (Zhou et al. 2007)

Notes

- sea cucumber extract has been shown to have potent anti-tumor effects in vitro (Tian et al. 2007; Zhang et al. 2006a; Zhang et al. 2006b; Tong et al. 2005)

 


 

Cetyl Alcohol (current percentage unknown)

Material Safety Data Sheet (100% cetyl alcohol)

Safety/Toxicity Studies

- dermal LD50 in the rabbit is greater than 2.6 grams/kg

- repeated or prolonged exposure is not known to aggravate medical conditions

- lowest published lethal dose is 10 grams/kg (guinea pig dermal exposure)

Notes

- found in many over-the-counter products including Aveeno daily moisturizing lotion

- found to be non-comedogenic (non-pore clogging) using a rabbit model (Nguyen et al. 2007)

 


 

Glycol Stearate (Glyceryl Monostearate) (current percentage unknown)

Safety: topical glyceryl monostearate

- glyceryl monostearate is safe for use in cosmetic formulations (Int. J. Toxicol. 2004)

Material Safety Data Sheet (100% glyceryl monostearate)

Safety/Toxicity Studies

- repeated or prolonged exposure is not known to aggravate medical conditions

 


 

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