Fungicillin

Fungicillin™ is a powerful broad spectrum antifungal created by FixaFungus and composed of natural organic compounds extracted from a variety essential oils and food additives. The proprietary blend includes derivatives, distillates and extracts of Manuka oil, red thyme oil, oil of oregano, Foraha/Tamanu oil, turpentine, castor oil, Melaleuca oil, clove tree, eucalyptus and garlic. An analysis of the component ingredients shows that most individual components act as antifungals. Additionally, further analysis indicates that the individual components work synergistically to alleviate the symptoms of fungal infections by killing both the fungus and secondary bacterial infections. Fungacillin is a component of a number of FixaFungus’s products including Toe and Nail Treatment. This report summarizes what is currently known about the safety and effectiveness of Fungicillin™ component ingredients.

Fungicillin: Safety and Efficacy

Fungal Infections

Fungi (the plural of fungus) colonize health human skin and orifices. In other words, we have a certain number of fungi on our skin and in our mouths, noses and other body openings at all times. When these organisms reproduce and reach large numbers, they can cause various clinical problems. One of the most common fungal infections in humans is dermatophytoses. Dermatophytes are fungi that cause illnesses with names such as athlete’s foot (tinea pedis), jock itch, (tinea cruris), ringworm (tinea capitis, corpora, or faciei) and onchomycosis, which is a fungal infection of the nails. Fungi tend to affect moist areas of the body, such as folds of the skin and between toes and fingers. The mouth and vagina are commonly affected areas, usually by a fungus called Candida (often Candida albicans). Infection in these areas causes oral thrush and yeast infections, respectively. An infection with Candida is also generically referred to as candidiasis and can occur anywhere on or in the body.

Individual Components are Non-toxic

The FDA uses a term “Generally Recognized as Safe” (GRAS) to refer to food additives that experts generally agree are safe for use in food products. More than half of Fungicillin’s active ingredients or their sources have been designated GRAS by the FDA, including thyme, oregano, clove tree, eucalyptus, castor oil and garlic. Manuka oil, Melaleuca oil, Foraha/Tamanu oil and turpentine irritate skin at high concentrations and are harmful if swallowed. Fungicillin is therefore for external use only. While the relatively low concentrations of these latter substances may such a reaction unlikely, if the skin becomes irritated with this product, it should be discontinued temporarily.

Synergistic Effects

Fungicillin™ is a particularly intriguing antifungal product because research demonstrates that its effectiveness is greater than the sum of its parts. Most ingredients are potent antifungal agents that kill the primary fungal infection by various mechanisms. Taken together, these ingredients kill a wide variety of fungi by different means. Certain components aid others by achieving greater potency or effect (e.g. the concentrating effect of carvacrol) thereby potentiating their antimicrobial activity. Many agents also possess antibacterial activity and treat/prevent secondary bacterial infections, also known as superinfections. The component ingredients in this formula therefore work synergistically to treat fungal infections common to the skin and mucosal surfaces. In addition, each of the components is safe and effective for topical use when used as directed.

Manuka Oil
Manuka oil is an essential oil extracted from shrubs or small trees called Leptospermum scoparium (Myrtaceae) that grow in New Zealand.1 It has been used as an antiseptic in medicine for thousands of years and is expecially prized for its high antimicrobial activity.1,2 The Manuka oil found in fungicillin is a re-distillation that concentrates three important triketones, leptospermone,iso-leptospermone and flavesone. In addition to potent activity against Gram-positive bacteria, the high beta-triketone content of Manuka oil makes it particularly effective against dermatophytes.3 Dermatophytes are the cause of various dermatological fungal infections such as toenail fungus, jock itch, athlete’s foot and ringworm. Manuka oil has virucidal (virus-killing) activity. The essential oil was able to kill Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2).2 HSV-1 and HSV-2 are the viruses the most common causes of cold sores and genital warts, respectively.

In high concentrations, Manuka oil may be irritating to skin and eyes so should only be used as directed. In one in vitro toxicology study, Manuka oil relaxed smooth muscle.4 While it is unclear whether this effect would translate to a meaningful consequence in humans, Manuka oil should be used topically rather than internally, especially in pregnant women.

Oil of Oregano

Oil of Oregano is extracted from herb oregano (Genus: Origanum), traditionally used in cooking. Origanum has several important components, including carvacrol and thymol. Carvacrol has long been used to treat parasitic diseases.5 Carvacrol and thymol both exhibit significant antibacterial activity against food-borne pathogens.6 They act synergistically against bacterium that cause disease in humans. Carvacrol is also used as a food preservative based on its antifungal properties.7 It significantly inhibits growth of many parasitic, disease-causing fungi in vitro. Extracts of oregano improve wound healing over petroleum-jelly alone, mainly due to its antimicrobial effects.8

Importantly, the essential oil of oregano is a broad-spectrum fungicide and has activity against the fungi common in respiratory and skin infections.9 Of particular interest is the oil of oregano in drug-resistant Candida infections of the fingernails, called Candidal Onychomycosis, which can occur in people whose hands are repeatedly immersed in water. Candida species, as mentioned, are also the main cause of yeast infections in women. While the essential oil of oregano was able to kill various Candida species in vitro, including those susceptible to the prescription drug fluconazole, oregano oil was even more potent at killing drug-resistant strains of the fungus.10

Red Thyme Oil

Thyme (genus Thymus) has a long history of being used in both food preparation and medicine. Red Thyme oil is an essential oil of the cooking herb and is known to possess antibacterial properties.6 Thyme oil is used as a preservative for food placed in storage because it prevents fungal-based spoiling of baked goods.11 Like oregano, the main active ingredients isolated from thyme oil are thymol and carvacrol, along with p-cymene and g-terpinene.12 Terpinene and p-cymene are thought to increase the uptake of carvacrol into bacterial cells thereby increasing its antibacterial activity.

The essential oils of Thymus, possess some remarkable antifungal activities. In fact, oils obtained from common time (Thymus vulgaris) displayed greater antifungal activity than a commercial fungicide, bifonazole.13 Moreover, an essential oil of Thymus was effective against various fungi including Candida, Cryptococcus, Aspergillus and dermatophyte species.14

Foraha/Tamanu oil

Tamanu (or Foraha) oil is an essential oil extracted from nuts or nut kernels of the Tamanu tree, called Calophyllum inophyllum, which grows in tropical areas. It is traditionally used in medicine for pain relief for minor ailments.15 The oil is non-toxic, according to product information regarding the pure oil. Friedelin is the main active ingredient isolated from the oil.16 When extracted and purified from the oil, it significantly inhibits the growth of the most common human pathogenic fungal strains.16 Canophyllol, canophyllic acid and inophynone have no effect on fungal growth, yet are also used in Fungicillin.16 Based on their significant antibacterial activity, they may assist the uptake of friedlelin into cells and thus have a synergistic effect.4,16 At the standardized concentrations present in FixaFungus’s Fungicillin, these active ingredients are safe for use by healthy individuals.

Delta-3-Carene

Delta-3-Carene is isolated from pine oil extract of turpentine. Turpentine is used in many cleaning and sanitary products. Aromatic species isolated from other Juneperus plants were traditionally used as antiseptics. In in vitro studies, extracts of pine oil, namely delta-3-carene, are effective at killing fungi that cause skin disease in humans including dermatophyte, Aspergillus and Candida species and strains.17 In addition, filamentous fungi of the genus Fusarium are susceptible to pine oil extracts.18

The concentration of turpentine present in Fungicillin should not cause significant skin irritation in the standard amounts. It is prudent to be judicious in Fungicillin use and stop treatment if the skin does become irritated.

Undecylenic acid

Researchers have known of Undecylenic acid’s potent antifungal properties since the 1950s.19 Undecylenic acid is a common constituent in many over-the-counter topical antifungal medications and has been approved by the FDA for this use since 1974. This naturally occurring acetylenic acid, derived from castor oil, has potent antifungal properties in vitro.20 More importantly, however, the ingredient has been shown in clinical trials to be an effective treatment for athlete’s foot (tinea pedis)20,21 and dermatophyte infections in other areas of the skin, such as surrounding the nail.22 Undecylenic acid also has activity against Candida albicans,20,23 the fungal species that is responsible for various types of Candidiasis in areas such as the mouth, esophagus, skin folds, and groin among others. Undecylenic acid prevents Candida from undergoing important structural changes in its life cycle, specifically changing from yeast to hyphae, thereby preventing it from reproducing.23 In addition to its antifungal activity, undecylenic acid is active against HSV-1 and reduced the duration and severity if cold sores in patients that initiated early treatment.24

Tea Tree Oil (Melaleuca Oil)

Tea tree oil isolated from Melaleuca alternifolia is an essential oil traditionally used as a topical therapeutic in Australia25, now used in many consumer products. It has antiflammatory, antimicrobial and antifungal properties.25,26 Tea tree oil is best known for its ability to kill bacteria though it has broad spectrum antimicrobial effects3,4 against bacteria and yeasts, including Candida species.27 This essential oil of the tea tree has various constituents that have their own documented antifungal activity including terpinen-4-ol, alpha-terpinol, linalool, alpha-pinene and beta-pinene.26  There is over 80 years of anecdotal evidence suggesting tea tree oil is safe for topical use, and that side effects are minor, self-limiting and occasional.25 Published research indicates that when high concentrations are used, it irritates skin and may be toxic when ingested; however the concentration used in Fungicillin is standardized, so it should be safe for use by healthy individuals.

Clove Tree Oil

Clove has long been used in cooking and medicine. Clove tree oil or clove oil is extracted from the flower bud of the clove, mostly, but is also present in the stems and leaves of the plant. Clove’s traditional uses include treatment of damaged skin, toothaches, digestive complaints, bronchitis, diarrhea and hernia. Clove oil’s main component, eugenol, is frequently used as a food preservative because of its potent antifungal properties.11 Eugenol is listed as GRAS by the FDA and is known to possess antibacterial properties.11 Clove oil and eugenol are effective antifungals in the treatment of Candida, Aspergillus and dermatophyte infections.28

Clove oil, specifically eugenol, has been used most extensively in dentistry as part of dental amalgams because it is bacteriostatic (prevents the reproduction of bacteria) and antiseptic and is gentler on the mouth than other cements.29 As its use in dentistry emerged, the broad antifungal properties became widely known. Clove oil is effective against the Candida species that frequently afflict denture wearers30 and the species that most commonly affects human skin, Candida albicans.31

In a clinical trial, eugenol (present in clove tree oil) when combined with thymol (present in fungicillin as components of oregano and thyme oils) was as effective as prescription medicines used in the treatment of bacterial vaginosis and vaginal candidiasis. Eugenol plus thymol was also as effective as metronidazole in treating bacterial vaginosis and econazole in treating vaginal candidiasis.32

Clove tree oil is safe for consumption by healthy individuals. At high concentrations, it may cause skin irritation; however, it is safe for healthy individuals in the standardized concentrations present in Fungicillin.

Eucalyptus

Eucalyptus is listed as GRAS by the FDA, and is known to possess antibacterial properties.33The oil is a potent anti-fungal, successful at killing many plant pathogenic fungi in vitro.33 Eucalyptus oil possess activity against Candida ablicans and has seen some use as a mouth rinse.34 Likewise, eucalyptus was shown to be effective in treating onychomycosis, which is a fungal nail infection caused by dermatophytes.35,36 Eucalyptus is safe for consumption by healthy individuals. Like Manuka oil, eucalyptus decreases the force of smooth muscle contractions so should be used with caution in women who are pregnant.4

Allicin

Garlic is listed is GRAS by the FDA. It is traditionally used to prevent and treat colds, and is present in a variety of consumer products. Its main antifungal component is allicin, which is extracted using a technique patented by Dr. Peter Josling for use in Fungicillin. In vitro, allicin significantly inhibits growth offungi including Candida, Cryptococcus, Trichophyton, Epidermophyton, and Microsporum,37 the latter three are dermatophytes commonly responsible for causing fungal infections of the feet. Allicin may enhance the antifungal effect of certain prescription antifungal agents such as Amphotercin B38 and fluconazole.39

NOTICE

This information has not been evaluated by the FDA and the information in this report is for informational purposes only and is not intended to diagnose, treat, cure, or prevent any disease. You should speak with a licensed physician before engaging in any new treatment regimen, especially if you have existing health problems.

References

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2.         Reichling J, Koch C, Stahl-Biskup E, Sojka C, Schnitzler P. Virucidal activity of a beta-triketone-rich essential oil of Leptospermum scoparium (manuka oil) against HSV-1 and HSV-2 in cell culture. Planta Med. Dec 2005;71(12):1123-1127.

3.         Christoph F, Kaulfers PM, Stahl-Biskup E. A comparative study of the in vitro antimicrobial activity of tea tree oils s.l. with special reference to the activity of beta-triketones. Planta Med. Aug 2000;66(6):556-560.

4.         Lis-Balchin M, Hart SL, Deans SG. Pharmacological and antimicrobial studies on different tea-tree oils (Melaleuca alternifolia, Leptospermum scoparium or Manuka and Kunzea ericoides or Kanuka), originating in Australia and New Zealand. Phytother Res. Dec 2000;14(8):623-629.

5.         Monzote L, Stamberg W, Staniek K, Gille L. Toxic effects of carvacrol, caryophyllene oxide, and ascaridole from essential oil of Chenopodium ambrosioides on mitochondria. Toxicol Appl Pharmacol. Nov 1 2009;240(3):337-347.

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8.         Ragi J, Pappert A, Rao B, Havkin-Frenkel D, Milgraum S. Oregano extract ointment for wound healing: a randomized, double-blind, petrolatum-controlled study evaluating efficacy. J Drugs Dermatol. Oct 2011;10(10):1168-1172.

9.         Vale-Silva L, Silva MJ, Oliveira D, et al. Correlation of the chemical composition of essential oils from Origanum vulgare subsp. virens with their in vitro activity against pathogenic yeasts and filamentous fungi. J Med Microbiol. Feb 2012;61(Pt 2):252-260.

10.       Pozzatti P, Scheid LA, Spader TB, Atayde ML, Santurio JM, Alves SH. In vitro activity of essential oils extracted from plants used as spices against fluconazole-resistant and fluconazole-susceptible Candida spp. Can J Microbiol. Nov 2008;54(11):950-956.

11.       Guynot ME, Ramos AJ, Seto L, Purroy P, Sanchis V, Marin S. Antifungal activity of volatile compounds generated by essential oils against fungi commonly causing deterioration of bakery products. J Appl Microbiol. 2003;94(5):893-899.

12.       Nostro A, Roccaro AS, Bisignano G, et al. Effects of oregano, carvacrol and thymol on Staphylococcus aureus and Staphylococcus epidermidis biofilms. J Med Microbiol. April 1, 2007 2007;56(4):519-523.

13.       Sokovic MD, Vukojevic J, Marin PD, Brkic DD, Vajs V, van Griensven LJ. Chemical composition of essential oils of Thymus and Mentha species and their antifungal activities. Molecules. 2009;14(1):238-249.

14.       Vale-Silva LA, Goncalves MJ, Cavaleiro C, Salgueiro L, Pinto E. Antifungal activity of the essential oil of Thymus x viciosoi against Candida, Cryptococcus, Aspergillus and dermatophyte species. Planta Med. Jun 2010;76(9):882-888.

15.       Dweck AC, Meadows T. Tamanu (Calophyllum inophyllum) – the African, Asian, Polynesian and Pacific Panacea. Int J Cosmet Sci. Dec 2002;24(6):341-348.

16.       Ali MS, Mahmud S, Perveen S, Rizwani GH, Ahmad VU. Screening for the Antimicrobial Properties of the Leaves of Calophyllum inophyllum Linn. Jour. Chem. Soc. Pak. 1999;21(1):174-178.

17.       Cavaleiro C, Pinto E, Goncalves MJ, Salgueiro L. Antifungal activity of Juniperus essential oils against dermatophyte, Aspergillus and Candida strains. J Appl Microbiol. Jun 2006;100(6):1333-1338.

18.       Krauze-Baranowska M, Mardarowicz M, Wiwart M, Poblocka L, Dynowska M. Antifungal activity of the essential oils from some species of the genus Pinus. Z Naturforsch C. May-Jun 2002;57(5-6):478-482.

19.       Prince HN. Effect of pH on the antifungal activity of undecylenic acid and its calcium salt. J Bacteriol. Dec 1959;78:788-791.

20.       Li XC, Jacob MR, Khan SI, et al. Potent in vitro antifungal activities of naturally occurring acetylenic acids. Antimicrob Agents Chemother. Jul 2008;52(7):2442-2448.

21.       Tschen EH, Becker LE, Ulrich JA, Hoge WH, Smith EB. Comparison of over-the-counter agents for tinea pedis. Cutis. May 1979;23(5):696-698.

22.       Battistini F, Cordero C, Urcuyo FG, Rojas RF, Ollague W, Zaias N. The treatment of dermatophytoses of the glabrous skin: a comparison of undecylenic acid and its salt versus tolnaftate. Int J Dermatol. Jul-Aug 1983;22(6):388-389.

23.       McLain N, Ascanio R, Baker C, Strohaver RA, Dolan JW. Undecylenic acid inhibits morphogenesis of Candida albicans. Antimicrob Agents Chemother. Oct 2000;44(10):2873-2875.

24.       Shafran SD, Sacks SL, Aoki FY, et al. Topical undecylenic acid for herpes simplex labialis: a multicenter, placebo-controlled trial. J Infect Dis. Jul 1997;176(1):78-83.

25.       Hammer KA, Carson CF, Riley TV, Nielsen JB. A review of the toxicity of Melaleuca alternifolia (tea tree) oil. Food Chem Toxicol. May 2006;44(5):616-625.

26.       Hammer KA, Carson CF, Riley TV. Antifungal activity of the components of Melaleuca alternifolia (tea tree) oil. J Appl Microbiol. 2003;95(4):853-860.

27.       Irkin R, Korukluoglu M. Growth inhibition of pathogenic bacteria and some yeasts by selected essential oils and survival of L. monocytogenes and C. albicans in apple-carrot juice. Foodborne Pathog Dis. Apr 2009;6(3):387-394.

28.       Pinto E, Vale-Silva L, Cavaleiro C, Salgueiro L. Antifungal activity of the clove essential oil from Syzygium aromaticum on Candida, Aspergillus and dermatophyte species. J Med Microbiol. Nov 2009;58(Pt 11):1454-1462.

29.       Brauer GM. [Zinc oxide-eugenol as dental material (1)]. Dtsch Zahnarztl Z. Nov 1976;31(11):824-834.

30.       Marcos-Arias C, Eraso E, Madariaga L, Quindos G. In vitro activities of natural products against oral Candida isolates from denture wearers. BMC Complement Altern Med. 2011;11:119.

31.       Cassanho AC, Fernandes AM, Oliveira LD, Carvalho CA, Jorge AO, Koga-Ito CY. In vitro activity of zinc oxide-eugenol and glass ionomer cements on Candida albicans. Braz Oral Res. Apr-Jun 2005;19(2):134-138.

32.       Sosto F, Benvenuti C. Controlled study on thymol + eugenol vaginal douche versus econazole in vaginal candidiasis and metronidazole in bacterial vaginosis. Arzneimittelforschung. 2011;61(2):126-131.

33.       Ramezani H, Singh HP, Batish DR, Kohli RK. Antifungal activity of the volatile oil of Eucalyptus citriodora. Fitoterapia. Jun 2002;73(3):261-262.

34.       Carvalhinho S, Costa AM, Coelho AC, Martins E, Sampaio A. Susceptibilities of Candida albicans Mouth Isolates to Antifungal Agents, Essentials Oils and Mouth Rinses. Mycopathologia. Jan 14 2012.

35.       Derby R, Rohal P, Jackson C, Beutler A, Olsen C. Novel treatment of onychomycosis using over-the-counter mentholated ointment: a clinical case series. J Am Board Fam Med. Jan-Feb 2011;24(1):69-74.

36.       Ramsewak RS, Nair MG, Stommel M, Selanders L. In vitro antagonistic activity of monoterpenes and their mixtures against ‘toe nail fungus’ pathogens. Phytother Res. Apr 2003;17(4):376-379.

37.       Yamada Y, Azuma K. Evaluation of the in vitro antifungal activity of allicin. Antimicrob Agents Chemother. Apr 1977;11(4):743-749.

38.       Ogita A, Fujita K, Tanaka T. Enhancing effects on vacuole-targeting fungicidal activity of amphotericin B. Front Microbiol. 2012;3:100.

39.       Khodavandi A, Alizadeh F, Harmal NS, et al. Comparison between efficacy of allicin and fluconazole against Candida albicans in vitro and in a systemic candidiasis mouse model. FEMS Microbiol Lett. Feb 2011;315(2):87-93.


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