EPILINE® – MASTER DISCLAIMER & PRODUCT OVERVIEW

1. Product Nature & Intended Use

  1. Cosmetic-Only Classification
    • Epiline® is a topical cosmetic product developed by Geneworks.
    • It contains bio-identically replicated recombinant human umbilical cord stem cell growth factors with sequence modifications designed for enhanced cell and skin penetration.
    • Epiline® is not FDA-approved or licensed as a drug, device, or biologic to diagnose, treat, cure, or prevent any disease.
  2. Topical Application Only – Do Not Inject
    • Epiline® is strictly for external use on intact skin.
    • Injection, ingestion, inhalation, or other off-label uses are expressly forbidden.
    • Misuse may violate federal or local laws or regulations.
  3. Adult Use Only
    • Epiline® is intended for use by healthy adults 18 years of age or older.
    • It is not recommended for children, adolescents, pregnant or nursing individuals, or anyone with compromised health without explicit medical clearance.

 

2. No Guaranteed Outcome / Results May Vary

  1. Variability in Individual Response
    • Due to unique skin physiology and external factors (age, genetics, environment, lifestyle), individual results may vary significantly.
    • No specific degree of improvement or timeframe is promised.
  2. Advanced Bioactive Ingredients – Cosmetic Purpose Only
    • While the bioactive growth factors used in Epiline® may show “drug-like” properties in purely scientific or research contexts, Epiline® is sold solely as a cosmetic.
    • No guarantees are made about efficacy, longevity of results, or suitability for any particular purpose beyond appearance enhancement.
  3. Not a Substitute for Medical Treatment
    • Epiline® does not replace professional healthcare or prescribed medications.
    • Consult a qualified medical professional if you have any underlying skin conditions or health concerns.

 

3. Safety, Patch Testing & Possible Reactions

  1. Patch Test Recommended
    • Users are advised to perform a patch test (e.g., on the forearm) before full application to check for adverse reactions such as redness, itching, or irritation.
    • If discomfort persists, discontinue use immediately and, if necessary, seek medical advice.
  2. Potential Cosmetic Irritations
    • Epiline® may cause mild, transient redness, dryness, tingling, or other normal reactions commonly associated with topical cosmetics.
    • If severe or persistent symptoms occur, discontinue use and consult a healthcare provider.
  3. Not Liable for Individual Allergies or Intolerances
    • Users are responsible for verifying personal allergies or sensitivities. Geneworks is not liable for allergic or other adverse reactions stemming from undisclosed conditions.

 

4. Instructions for Use & Storage

  1. Follow Packaging Instructions
    • Use Epiline® strictly as described in the accompanying packaging or official documentation.
    • Any deviation from recommended instructions (e.g., mixing with non-approved substances, using on broken skin, combining with invasive procedures) is at the user’s own risk.
  2. Proper Storage
    • Epiline® is cryogenically freeze-preserved. Follow instructions regarding thawing, refrigeration, or temperature stability.
    • Improper storage can degrade the product’s quality, leading to reduced effectiveness or possible skin irritation.
  3. No Modification or Repackaging
    • Do not alter the product, transfer it to unapproved containers, or repurpose it in ways not intended. Unauthorized repackaging or relabeling may violate laws and void any implied warranties.

 

5. Regulatory & Legal Disclaimers

  1. Not Evaluated by the FDA for Drug Use
    • Statements made about Epiline® have not been evaluated by the U.S. Food and Drug Administration for drug claims.
    • Epiline® is not intended to diagnose, treat, cure, or prevent any disease.
  2. Misuse & Unapproved Drug Claims
    • Marketing Epiline® (or any Geneworks product) as a drug or for therapeutic use is prohibited and may constitute a violation of federal law.
    • Geneworks disclaims liability for any user or third party misrepresenting Epiline® as a medical product.
  3. Compliance with Local Laws
    • Users are responsible for complying with all applicable local laws, regulations, and guidelines relating to cosmetic products.
    • Epiline® may be restricted or prohibited in certain regions; it is the user’s responsibility to verify local requirements before purchase or use.

 

6. Limitations of Liability & Indemnification

  1. No Warranties
    • To the fullest extent permitted by law, Geneworks disclaims all warranties, whether express or implied, including implied warranties of merchantability or fitness for a particular purpose.
  2. Limitation of Liability
    • Notwithstanding anything to the contrary, in no event shall the total aggregate liability of Geneworks, its affiliates, employees, or agents exceed the lesser of (a) the total amount paid by you for Epiline® in the twelve (12) months preceding the event giving rise to the claim, or (b) $500. This limitation applies regardless of the form or theory of the claim or cause of action (e.g., contract, tort, strict liability, or otherwise).
    • By purchasing or using Epiline®, you agree to defend, indemnify, and hold harmless Geneworks, its officers, directors, employees, and affiliates from any claims, damages, losses, liabilities, and expenses (including attorney fees) arising from or related to:
      a. Misuse of Epiline® (including unauthorized injection, off-label usage, or combination with invasive procedures).
      b. False or misleading drug claims made by you or a third party acting on your behalf.
      c. Failure to adhere to any disclaimers, instructions, or warnings provided.

 

7. No Oral Modifications; Entire Agreement

  1. No Oral Modifications
    • All representations regarding Epiline® must be in writing. Verbal agreements or claims are invalid unless included in a formal amendment signed by an authorized Geneworks representative.
  2. Entire Agreement
    • This disclaimer, alongside any written instructions or product inserts, constitutes the entire understanding between Geneworks and the user concerning Epiline®.
    • It supersedes all prior or contemporaneous communications, whether oral or written.

 

8. Governing Law & Dispute Resolution

  1. Governing Law
    • Any disputes related to Epiline® or this disclaimer shall be governed by the laws of Denton County TEXAS, without regard to its conflict of laws principles.
  2. Forum Selection / Arbitration Binding, Non-Binding or Civil at Geneworks LLC or Geneworks USA preferential choice.
    • All controversies shall be resolved  in Denton County, TEXAS or, if required, in the courts of Argyle, TEXAS having jurisdiction.
  3. Severability
    • If any provision (or portion thereof) of this Agreement (including any disclaimers) is found invalid or unenforceable, the remaining provisions shall remain in effect and be enforced to the maximum extent permissible. The provision in question shall be deemed modified only to the minimum extent necessary to render it valid and enforceable, while preserving the original intent of the parties to the fullest extent allowed by law.

9. Acceptance of Terms

By purchasing, opening, or using Epiline®, you acknowledge that you have read and understood the entirety of this Master Disclaimer & Product Overview, and you agree to be bound by its terms. If you do not accept these terms, do not use Epiline® and promptly return it to your place of purchase (subject to the return policy).

 

EPILINE® is a cryogenically freeze-preserved topical cosmetic product containing bio-identically replicated recombinant human umbilical cord stem cell growth factors with sequence modifications for cell and skin penetration. EPILINE® is intended for topical application only—DO NOT INJECT—and is recommended for adult use. Misuse may be a violation of federal law.

While EPILINE® utilizes advanced bioactive ingredients that may exhibit potent properties in certain medical or research contexts, we do not guarantee any specific results or outcomes for individual users. Every person’s skin is unique and can respond differently due to factors like age, genetics, environment, and overall health. As such, results may vary.

EPILINE® is sold exclusively as a cosmetic product, intended to improve the appearance of skin. It is not licensed or approved as a drug and is not intended to diagnose, treat, cure, or prevent any disease or medical condition. If you have concerns about your skin or health, consult a qualified medical professional.

Geneworks manufactures and designs biologic, OTC, dietary supplements, and cosmetic skincare solutions. Some of our biologic or OTC products are formulated to support specific wellness needs, but their use does not replace professional medical advice or treatment. Always follow product packaging instructions and consult your healthcare provider with any questions or concerns.

The statements made regarding EPILINE® or any Geneworks products have not been evaluated by the U.S. Food and Drug Administration (FDA) for drug efficacy. The use of these products is solely for cosmetic and general wellness purposes. No therapeutic or medical claims are asserted or implied.