Hello future tattoo removal professional!
Thank you for your interest in the Tattoo Removal Training Technique by the Linda Paradis Group using the patented needles 88.
Here at IBEE we strive to work with products we believe in, and so it is with the tattoo removal product line and technique by Linda Paradis Group using the patented needles 88. Having the safety of our students and clients in mind, we will list here some documents which we find will educate you on regulation of the products used in this technique both in the USA and Europe.
When you are certain that you are working with a product that contains no harmful ingredients, no acids or saline solution, and that will keep your clients' skin intact during the entire procedure, it completely changes your outlook on the product and how confident you are when you offer your services to your client. Safety and peace of mind should always be present in our day-to-day practice in our studios, clinics and salon. Our customers satisfaction comes first and this product and technique will certainly allow you to deliver fantastic results with 100% safety.
Country of Origin/Cerficate of Free Sale: The Tattoo Removal product is made in the USA by Cynergy Laboratories located in New York. A Certificate of Free Sale has been issued by the Manhattan Chamber of Commerce to both the laboratory and Linda Paradis Product. A Certificate of Free Sale is evidence that goods, such as food items, cosmetics, biologics, or medical devices are legally sold or distributed in the open market, freely without restriction, and approved by the regulatory authorities (FDA) in the country of origin, in this case, the United States. The Certificate of Free Sale issued by the Manhatan Chamber of Commerce on October 25, 2016 is attached for your reference. We invite you to review it. (Doc 1)
FDA Regulation: The tattoo removal serum by the Linda Paradis Group has been voluntary registered with the FDA via the Form 2512 in the Voluntary Cosmetic Registration Program (VCRP). The VCRP allows companies to register their cosmetic products and ingredients being distributed in the US market. The VCRP is not a cosmetic approval program as cosmetics are not subject to FDA premarket approval. However, through this program companies ensure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law. The Form 2512 filed with the FDA is attached for your reference. We invite you to review it and look at the ingredients listed. (Doc 2)
MSDS Report: The Material Safety Data Sheet is a document that contains information on the potential hazards (health, fire, reactivity and environmental) and how to work safely with the chemical product. It is an essential starting point for the development of a complete health and safety program. The MSDS for the tattoo removal product contains information on the use, storage, shelf life, composition and information on the ingredients, among of other important information. The MSDS contains much more information about the material than the label. MSDSs are prepared by the supplier or manufacturer of the material. It is intended to tell what the hazards of the product are, how to use the product safely, what to expect if the recommendations are not followed, what to do if accidents occur, how to recognize symptoms of overexposure, and what to do if such incidents occur.
Even though the Tattoo Removal Product along with needles 88 is an absolutely safe product as it contains no acids or saline solutions, we have attached hereto the MSDS report having your safety and the safety of your clients in mind. It brings to us PMU professionals peace of mind to know that we are offering our clients a product that is not only natural, but it is also safe. We invite you to review the attached report. (Doc 3)
CPNP - Having the safety of European professionals in mind, the Linda Paradis Group has also filed a CPNP registration (Cosmetic Products Notification Portal). The CPNP is an electronic interface that supports the implementation of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. In practical legal terms, but not literally, The CPNP in Europe is somewhat compared to the FDA in the USA. The CNPN registration confirmation report is attached for your review. (Doc 4)
Aftercare Clinical Research Report - A 96 hours patch test was performed in 30 healthy males and females to investigate the skin irritation potential and no adverse reactions or irritations were reported. The report dated of March 2014 is attached for your review. (Doc 5)
A Cosmetic Health Assessment and Safety Data Sheet was issued for the Aftercare Balm, and the findings were that the formulation and composition is safe for use and complies with the EU Cosmetics Directive 76/768/EEC(4) and the UK Cosmetics Products (Safety) Regulations 2008. The report is attached for your review. Doc (6)
A Safety Data Sheet for the Sweet Gel Cleanser was issued on December of 2015 by SDS Manufacturing, Inc. in Sun Valley, CA. The report is attached for your review. (Doc 7)
A Sterilization report is also available upon request for the needles 88 as well as other needles.
Simone & Team