Cosmetic classification and disclosures

Cosmetic classification

BioRNA is a cosmetic product intended to improve the appearance of skin and scars. It is not a drug or a medical device. It is not intended to diagnose, treat, cure or prevent any disease or condition.

Nothing on this site should be read as a claim that BioRNA treats, heals or prevents scarring, or affects the structure or function of the body.

FDA disclaimer

These statements have not been evaluated by the U.S. Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Study data and results

Figures presented on this site are drawn from investigator-reported study data and published literature supplied by the manufacturer, including a randomised, single-blinded, intraindividually controlled study of 50 participants.

Study results describe measured and observed changes in the appearance of scars. Individual results vary, and the results reported by study participants may not be typical.

Directions and safety

For external use only. Do not apply to open wounds, broken skin, infected skin or unhealed incisions. Begin only after the wound is fully closed or sutures have been removed.

Discontinue use and consult a physician if irritation, redness or discomfort occurs. A patch test is recommended for sensitive skin. Keep out of reach of children. Single use only — do not reuse a patch.

If you are pregnant, nursing, or under the care of a physician for a skin condition, speak with your healthcare provider before use.

No medical advice

This site is provided for general educational and informational purposes only and is not a substitute for professional medical advice, diagnosis or treatment. No physician–patient relationship is created by use of this site or by contacting us through it. Always seek the advice of a qualified healthcare provider with any questions about a scar or skin condition.

Regulatory and distribution

BioRNA is distributed in the United States. Cosmetic products marketed in the United States are subject to facility registration, product listing and responsible-person labelling requirements under the Modernization of Cosmetics Regulation Act (MoCRA). Product availability and labelling may differ by jurisdiction.

Terms of use and liability

All content, marks and imagery on this site are the property of their respective owners and may not be reproduced without permission. The site is provided on an “as is” basis without warranties of any kind. To the fullest extent permitted by law, BioRNA disclaims liability for any loss arising from reliance on information published here.

We collect only the information you submit through the enquiry form and use it solely to respond to your enquiry. We do not sell personal information.