Home Cosmetic Science Talk Formulating Challenge: Formulate a ingrown tonail / toenail fungus remover

  • Challenge: Formulate a ingrown tonail / toenail fungus remover

    Posted by Zink on April 21, 2014 at 12:52 am

    This is a personal one, I’ve had a fungus infected big toe nail for years, it’s grown really thick and gross.

    I read that high concentration urea can be used to remove it if applied several times daily under a compress, can any of you think of an easier way to fix this? Maybe a urea + acid two step treatment including the most powerful antifungal preservatives we know?
    In fact, what are the most powerful antifungals ok for cosmetic application?
    graillotion replied 2 weeks, 3 days ago 3 Members · 3 Replies
  • 3 Replies
  • microformulation

    April 21, 2014 at 10:52 am

    This is an area that I have some experience in.

    Firstly, an ingrown toenail and toenail fungus. Different causes, presentation of symptoms and treatment.

    An ingrown toenail is a physical condition where the toenail grows into the nail bed abnormally and causes pain. The most common cause is too aggressive trimming of the nails. In this case it is usually a minor outpatient procedure. A local anesthetic is applied, the nail removed in a sterile manner, antibiotics are prescribed, a dressing is applied and wound care follow-up is completed.

    Toe nail fungus (also known as  Onychomycosis or Tinea unguium) is an actual fungal infection of the nail. It is characterized by discoloration and thickening of the nail. The treatment centers around the use of Prescription or OTC topical products. The FDA has a monograph that will designate which anti-fungal actives can be used for the indication. Not every anti-fungal is approved. I have seen some “homeopathic” and/or “Natural” alternatives sold but I feel they encroach upon the OTC monograph in spirit. Also this is a case where an OTC or Physician involvement is warranted. NOT EVERYTHING HAS TO BE A NATURALLY INSPIRED PRODUCT. This is a case where established medicine has a strng history of effectiveness.

    Tinea ungium also is unique to other fungal infections. Most fungal infections (Tinea pedis, Tinea cruris) will have a “cosmetic” resolution well before they are fully eliminated. What this means is the redness, irritation and itching will resolve well before the fungus is fully cleared up. This is why most products are recommended to be used for a period of time after the cosmetic symptoms abate. Tinea ungium is the exception. The fungus can be totally eradicated but you will still see the “cosmetic” appearances for the most part until the nail is replaced through normal growth. The changes in the appearance (yellowing, thickened nails) can be addressed by nail care (filing, trimming, routine care) and many nail shops will provide this service.

    I see numerous “Cosmetic” products looking to treat this condition but I think we are remiss to provide these products. This is really a case where an OTC product is most warranted. While there is a strong belief in Natural Medicine and “natural” remedies we have an obligation to not interfere with appropriate Medical Management when warranted.

    I suppose your only recourse would be to make an OTC product but generally this requires a higher level of documentation, experience and Registartion with the FDA as an OTC Labeler.

    • graillotion

      November 12, 2023 at 1:25 am

      Aloha….I also have a perennial bout of toe-nail fungus. I have NO INTENTION of making a product to sell or distribute….just feel like I should be able to create something at home.

      4 minutes into my research…I have come across undecylenic acid….twice….at rates of 10-25%. If you were to concoct something at home…what would be your ‘go to’ ingredient/s?

      What about from a commercial OTC product…have you found one to work better than the others? I am also open to the idea of just buying something….as I have ZERO interest in this type of product….other than getting rid of my own concern.

      Aloha…..hehehe…yup wear slides 365…. so toes are always on display.

  • Zink

    April 21, 2014 at 2:01 pm
    It strike me that I haven’t tried any OTC remedies, so maybe this is a solved problem, seems like Tolnaftate 1% in a PEG solution in the morning and 25% undecylenic acid in the evening would be my best bet?

    Now if existing treatments do not work then I can make OTC formulations for my own toes all day - If one works for me i’d get in touch with a couple of doctors in Canada who can get treatments formulated at local compounding pharmacies, then if they’re happy, then crowdfund a production run at a OTC approved FDA registered facility (IF it’s better than what’s currently available).

    I just doubt that anything that doesn’t actually take the nail off will work at my advanced stage.

    Here’s the final monograph:

    The FM, or final rule, was published on September 23, 1993, and became effective on September 23, 1994 (Ref. 3).  In the FM, we reviewed about ten studies and found the following active ingredients to be GRASE for the treatment of athlete’s foot: 

    · clioquinol 3%

    · haloprogin 1%

    · miconazole nitrate 2%

    · povidone-iodine 10%

    · tolnaftate 1%

    · undecylenic acid and its salts (calcium, copper, and zinc) for a total undecylenate concentration of 10-25%

    We found all other ingredients considered in this rulemaking not to be GRASE for use in an OTC topical antifungal drug product.  In addition, the FM includes labeling similar to that recommended by the Panel in the ANPR.  All of the active ingredients are indicated for the treatment of athlete’s foot as well as the relief of symptoms due to athlete’s foot.  One active ingredient, tolfaftate, is indicated for the prevention of athlete’s foot.  In addition, the active ingredients are indicated for the treatment of ringworm (tinea corporis) and jock itch (tinea cruris).    

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