FDA Disclaimer
Last updated: August 30, 2026
Regulatory Statement
Statements on this website have not been evaluated by the Food and Drug Administration. KeraFirm Pro is not intended to diagnose, treat, cure, or prevent any disease. The information provided on this website is for general informational and educational purposes only.
Manufacturing Standards
KeraFirm Pro is produced in a facility that is FDA-registered and follows current Good Manufacturing Practice (cGMP) guidelines. FDA registration means the facility is on the FDA's registry of establishments that produce products under their oversight. It does not constitute approval or endorsement of the product itself by the FDA.
About Undecylenic Acid
Undecylenic acid is an active ingredient recognized under the FDA's Over-the-Counter (OTC) Drug Monograph 21 CFR Part 333 for topical antifungal use. This recognition applies to the active ingredient category and its permitted concentration range and does not extend to any specific brand or formulation as a whole.
Not a Substitute for Medical Care
The content on this website, including product descriptions, ingredient information, and results timelines, is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or nail concern.
Never disregard professional medical advice or delay seeking it because of something you read on this website. If you think you may have a medical condition, contact your healthcare provider promptly.
Individual Results Vary
Personal testimonials and results shown on this website are based on individual customer experiences and are not typical for all users. Results depend on numerous factors including consistency of use, individual biology, severity of the condition, and other health factors. No specific outcome is guaranteed.
Consultation Recommendations
Before beginning use of KeraFirm Pro, we recommend consulting a healthcare provider if you:
- Are pregnant, planning to become pregnant, or nursing.
- Are taking prescription medications.
- Have a diagnosed medical condition, including diabetes or immune disorders.
- Have known allergies to any of the ingredients listed on the product label.
- Are under 18 years of age.
Ingredient Transparency
The complete ingredient list is printed on every KeraFirm Pro bottle. If you have concerns about any specific ingredient or its interaction with your health situation, review the label with your healthcare provider before use.
External Use Only
KeraFirm Pro is formulated for external topical use on the nail and surrounding cuticle. Do not ingest. Avoid contact with the eyes. If accidentally swallowed, drink water and seek medical attention immediately.
Contact
For questions about the product or regulatory information, contact us at:
- Email: contact@kerafirmpro-product.com
- Phone: 1-800-390-6035