Formula 7® is a newly patented, paraben-free Soluble Tolnaftate antifungal microemulsion fortified with cosmetic ingredients and bactericidal agents.
What makes Formula 7® unique?
- Soluble Tolnaftate – A technology developed by The Tetra Corporation (U.S. Patent # 4,810,498) and used first in Formula 3®.
- Formula 7® is the first tolnaftate microemulsion – U.S. Patent Awarded 2021
- Formula 7® is formulated with cosmetic ingredients that rehydrate and restore the natural physical properties and appearance of the skin and nail with each use. The cosmetic ingredients are C12-15 Alkyl Benzoate, Jojoba Seed Oil, Glycerin, PEG-20 Hydrogenated Lanolin, Urea, Vitamin E Acetate, and Caprylyl Glycol.
- The N-acetyl-l-cysteine (NAC) in Formula 7® is a penetration enhancer specifically designed to increase tolnaftate flux through keratin. Studies have also found that NAC has bactericidal properties and breaks down bacterial biofilms of clinically relevant pathogens including Pseudomonas aeruginosa, Staphylococcus aureus, Enterococcus faecalis, Enterobacter cloacae, Staphylococcus epidermidis, and Klebsiella pneumoniae.
- Formula 7® contains urea to increase the water content of the top layers of the skin. Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and increasing permeability of the nail plate for cosmetic debridement.
- Melaleuca Alternifolia (Tea Tree) Oil adds benefits of an antifungal, antiseptic, germicidal and anti-bacterial properties.
- A new ½ fl. Oz. (15ml) tube with an integrated brush applicator for ease of use.
Is Formula 3® being replaced or will it continue to be available?
Formula 3® will continue to be available. Thousands of patients have had excellent results with Formula 3® and continue to use it for treatment and prophylaxis. We recognize this and plan to continue to manufacture this safe and effective treatment.
What’s the difference between Formula 3® and Formula 7®?
Formula 3® is a mixture of 5 oils. One of the oils, jojoba oil, is the vehicle that holds the drug, tolnaftate 1% USP, in solution (Tetra’s U.S. Patent # 4,810,498). Formula 7® is an oil in water microemulsion. The oil phase is comprised of the jojoba oil with the tolnaftate in solution and tea tree oil to fortify the microemulsion with antifungal, antiseptic, germicidal and anti-bacterial properties. The water phase contains N-acetyl-l-cysteine (NAC) and urea: urea to hydrate, soften, and open keratin for better drug penetration; NAC to increase the flux of tolnaftate through the keratin to the site of involvement and provide bactericidal properties. Formula 7® is clear, paraben free, fortified with bactericidal agents, and packaged in a free-flowing tube for easy application. Both Formula 3® and Formula 7®, like all our products, are dye and fragrance-free.
Should I use Formula 7® instead of Formula 3®?
Formula 7® is a different approach to the delivery of tolnaftate to the site of involvement. It is designed to be both a primary and a follow-up course of treatment if Formula 3® therapy was not effective. Your pathology, sensitivity to ingredients, medical history, compliance, and personal preference are sure to be key factors in the doctor’s prescription of each treatment.
Is there medical evidence to support Formula 7® effectiveness?
There are numerous peer-reviewed publications and an FDA monograph that provides clear evidence of the effectiveness of our formulation. We are happy to provide you with the abstracts of the peer-reviewed publications. Click here for the abstracts of the studies. (here is a link to What Published Studies Tell Us Acetylcysteine Urea Tea Tree Oil).
Why Does The Label Say; "Not Effective On Scalp Or Nails"?
Your doctor may prescribe Formula 7® Solution for off-label use when they judge that it is medically appropriate for you.