MESO-XANTHIN F199® harnesses the potent F199 Carotenoid to invigorate skin regeneration, target aging signs, and boost skin vitality. This advanced formula blends epigenetic science with natural ingredients, promoting a healthier, youthful complexion and enhancing cellular regeneration. Through its unique epigenetic benefits, this aesthetic solution kickstarts cellular repair processes, particularly for skin affected by oxidative stress and premature aging.
EPIGENETIC REGENERATION
Embracing the latest in epigenetic science and the potential of natural ingredients, our F199 Fucoxanthin platform leads modern skincare, providing optimal solutions for skin regeneration, anti-aging, and overall skin vitality.
This robust aesthetic solution also highlights benefits from the increased proliferation and differentiation of progenitor fibroblasts.
BENEFITS
MESO-XANTHIN F199® helps to target the genes responsible for synthesizing proteins involved in skin repair via epigenetic cellular skin therapy. It has shown numerous benefits, including:
- Diminishing pigmentation;
- Brightening dull skin;
- Restoring skin radiance;
- Reducing the appearance of wrinkles and fine lines;
- Preventing the onset of adult acne.
DEFENSE FROM PHOTOAGING
Our innovative aesthetic solution strengthens cells' inner antioxidant defenses, preventing skin aging onset. Rigorous testing showcases its positive impact on cell defense and survival in environments exposed to sun damage, pollution, smoking, and chemical irritants. Modified using distinct proprietary methods, the biological properties of this compound are reinforced, including its epigenetic mechanisms of action—aimed at up-regulating the synthesis of vital cellular proteins.
HOW IT WORKS
CELLULAR REGENERATION
MESO-XANTHIN F199® prevents the effects of photoaging and chronoaging at a cellular level, promoting damaged and mature skin regeneration. In synergy with MESO-WHARTON P199®, it enhances stem cell vitality, delays cell senescence, and extends cell lifespan, combating free radicals and aging at a cellular level.
EPIGENETIC MECHANISMS
It works in synergy with MESO-WHARTON P199® to harness epigenetics, sustain stem cell/fibroblast vitality, delay cell senescence & extend cell lifespan. This works at the cellular level to combat free radicals and aging by up-regulating cell-cycle defense through epigenetics—keeping skin cells functioning at optimum efficiency—by restoring the cells’ inner antioxidant defenses to prevent the onset of skin aging.
REGENERATE & REGULATE
DESIGNED FOR INTENSIVE DERMAL REGENERATION AND REGULATION OF THE SKIN’S METABOLIC PROCESSES
The key component is our proprietary F199 (Fucoxanthin) platform. The formulation contains fermentative hyaluronic acid in a non-crosslinked form and regulatory peptides, oligopeptides, vitamins, microelements, amino acids, and nucleic acids.
MESO-XANTHIN F199® injectable gel is presented in a 1.5 mL single-use glass syringe. This sterile, biodegradable, and non-pyrogenic gel, marked by its viscoelastic properties and pale yellow transparency, is specifically created for intradermal facial injections. Powered by the naturally safe F199 Fucoxanthin, it is expertly crafted to shield, fortify, and rejuvenate mature skin stem cells through epigenetic pathways while also encouraging regenerative actions on impaired and aged skin.
FOSTER CELLULAR REPAIR
MESO-XANTHIN F199® fosters cellular repair through epigenetic modification, particularly under high oxidative stress conditions that accelerate premature aging. It protects, defends, and promotes the proliferation and differentiation of progenitor skin cells.
CELLULAR OPTIMIZATION
MESO-XANTHIN F199® has a positive impact on cell cycle defense and on improving the cell survival rate under conditions of daily exposure to environmental cellular stresses, including sun, ozone, pollution, smoking, and chemical irritants. The treatment boosts cell cycle defense and enhances cell survival under daily environmental stressors, acting as a protective shield against the toll of time on our skin cells.
The external stimulation on parts of a signaling pathway acted upon by MESO-XANTHIN F199® carries out a bilateral regulatory interaction between the fibroblasts and the extracellular matrix, leading to the improvement of the skin’s appearance. This interaction causes the cell to “clean house,” which increases potential health-promoting effects, including a dramatic increase in skin radiance.
KEY COMPONENTS
HYALURONIC ACID
Hyaluronic acid is a key component in our formulations, offering remarkable benefits for the skin. It acts as a potent moisture infuser, locking in hydration and providing essential nourishment. This hydrating action helps to keep the skin supple, plump, and youthful in appearance.
At ABG Lab, we prioritize the quality of our ingredients. We source hyaluronic acid exclusively from reputable manufacturers who adhere to stringent good manufacturing practices. This ensures that the hyaluronic acid used in our products meets the highest standards of purity, efficacy, and safety.
In addition to its exceptional moisturizing abilities, hyaluronic acid also offers antioxidant protection. It acts as a shield, safeguarding the skin against environmental factors such as pollution, UV radiation, and oxidative stress. This protection helps to prevent damage caused by free radicals and supports the skin's natural defense mechanisms.
F199 FUCOXANTHIN
Experience the transformative effects of our specially-formulated—F199 Fucoxanthin. This potent carotenoid protects and renews your skin's DNA, effectively shielding it from oxidative stress and the impacts of aging. Our specially-formulated platform goes beyond superficial skin enhancement. It targets the genes responsible for protein synthesis integral to skin repair and regeneration. This unique compound scavenges harmful free radicals and defends against UV damage, providing comprehensive cellular defense.
Fucoxanthin, an antioxidant from brown seaweed, synergizes with the F199 Carotenoid, offering superior protection against environmental stressors and a radiant skin tone. This innovative platform maximizes efficacy, delivering transformative results for skin health and appearance.
In the pursuit of youthful, radiant skin, skincare capable of stabilizing cellular structure, mitigating damage, and optimizing repair mechanisms is crucial. Our F199 Fucoxanthin is the optimal solution for mature and aging skin. Studies have shown that our F199 Fucoxanthin formulation can significantly reduce cellular abnormalities in the skin and stimulate DNA synthesis, offering a protective effect on your skin's aging fibroblasts.
OLIGOPEPTIDE-1
An epidermal growth factor that promotes the proliferation of epithelial and endothelial cells, one of the most active “proliferators,”; slowing the chronological signs of skin aging and stimulating skin growth at the cellular level while increasing collagen production.
VITAMINS & MICRONUTRIENTS
Micronutrients, specifically antioxidants, play a vital role in skincare by protecting the skin from harmful free radicals and strengthening the skin barrier. These essential components work diligently to maintain the overall health and well-being of the skin.
Antioxidants act as powerful defenders against free radicals, which are unstable molecules that can cause oxidative stress and damage to the skin. Environmental factors such as pollution, UV radiation, and stress can generate free radicals, leading to premature aging, inflammation, and skin damage. Micronutrients with antioxidant properties neutralize these harmful free radicals, preventing their detrimental effects on the skin.
DEVICE INFORMATION
DIRECTIONS FOR USE (DFU)
PLEASE READ THE FOLLOWING INFORMATION THOROUGHLY BEFORE USE.
MESO-XANTHIN F199® gel is a homogenous, pale yellow, clear gel without particulates. If the contents show signs of separation or appear cloudy, please call ABG LAB at +1 (800) 682 5741.
MESO-XANTHIN F199® injectable gel is a sterile, biodegradable, non-pyrogenic, viscoelastic, pale yellow, transparent gel intended for facial intradermal injection. MESO-XANTHIN F199® is a solution designed for intensive dermal regeneration and regulation of the skin’s metabolic processes.
The formulation contains fermentative hyaluronic acid in a non-crosslinked form and regulatory peptides, oligopeptides, vitamins, microelements, amino acids, and nucleic acids.
MESO-XANTHIN F199® is a non-surgical cosmetic treatment indicated for the prevention of age-related skin changes (lines and wrinkles, loss of tone and elasticity, lax facial contour; preparation for plastic surgery; skin rehabilitation during the postoperative period; laser resurfacing, or various burns; surface or dermal dehydration; comprehensive treatment of hyperpigmentation; post-acne and smoker’s skin syndrome; and rosacea/seborrheic dermatitis-related conditions in adults over the age of 21.
MESO-XANTHIN F199® is a single-use device administered by a physician via multiple intradermal microinjections.
- Patients with severe allergies set on by a history of anaphylaxis or history/presence of severe allergies;
- Patients with previous hypersensitivity to hyaluronic acid or intolerance to one or more of the device’s constituents;
- Patients with bleeding disorders;
- Implantation in anatomical spaces other than the dermis.
- Postpone treatment at a site(s) in which an active inflammatory response (skin eruptions such as pimples, rashes, cysts, or hives) or infection is present until the response or infection has been treated.
- Do not implant MESO-XANTHIN F199® injectable gel into blood vessels. Take extra care when injecting soft tissue — checking to ensure proper insertion.
- Typical treatment response primarily centers around short-term inflammatory symptoms at the injection site, starting post-treatment and lasting up to three (3) days. Other potential adverse effects reported during post-market surveillance include short-term erythema, edema, pruritus, or moderate soreness in the injection sites. Reference the ADVERSE EVENTS section for more details.
- This device is meant to be used on a single patient in one treatment session. Do not resterilize. Observe sanitary and epidemiological requirements during any invasive procedures. Verify the integrity of the packaging before use. Do not use the device past the indicated shelf life or if the packaging has been damaged;
- The safety and effectiveness of this device for the treatment of the regions below have not been established in controlled clinical studies. During any transcutaneous procedure, there is a risk of infection - standard precautions associated with injectable materials should be adhered to;
- Any and all uses of this device outside of the intended uses or any modification/use outside of the stated Directions For Use may impact the quality, homogeneity, sterility, or performance of the device and its constituents;
- Do not use this device in conjunction with devices of similar nature and/or purpose. Avoid the treatment of similar sites within fourteen (14) days before or after treatment with Botulinum Toxin agent, use of chemical peeling, or laser treatment;
- The safety of this treatment for use in patients during pregnancy, breastfeeding, or in patients under 18 years has not been established. Use with caution in patients on immunosuppressive therapy or patients with bleeding disorders. Avoid site(s) with a permanent implant;
- Patients should avoid taking high doses of Vitamin A or E supplements, aspirin, or nonsteroidal anti-inflammatory medications prior to treatment as these products may increase bleeding or bruising at the injection site(s);
- Previous acute inflammatory elements (acne, herpes) or chronic skin diseases (cysts, pimples, rashes, or hives) in the area of the potential injection site(s) may experience an inflammatory response or reactivation of herpes;
- Refrain from using saunas or tanning salons while also avoiding direct sunlight between treatment sessions;
- Syringe contents, syringes, and needles must be safely discarded immediately after use to prevent potential biohazards. Dispose of these items in accordance with accepted medical guidelines and applicable local or federal requirements;
- MESO-XANTHIN F199® should only be used by licensed medical professionals with appropriate training, experience, and knowledge in the fields of anatomy at/around the injection site to maintain a safe, sterile, and effective treatment procedure. By encouraging discussion of the potential risks of soft tissue injection with patients prior to the procedure, clinicians can be sure that patients are aware of the symptoms and signs of potential complications;
- Failing to follow needle attachment instructions may result in needle disengagement or leakage at the LUER-LOK adaptor or connection, failure to adhere to recommended needle size or use of a needle larger than 32G can lead to improper distribution of the device, and the formation of large papules.
- After treatment with MESO-XANTHIN F199®, reactions related to invasive procedures may occur and continue for 1-3 days. These reactions include redness, swelling, itching, tenderness, and change in skin color at the injection site(s). Other known potential adverse effects reported during post-market surveillance include short-term erythema, edema, pruritus, or moderate soreness in the injection site(s) for 1-3 days.
Six hundred forty (640) subjects were enrolled in a randomized, double-blinded (subject and evaluator) clinical trial to evaluate the safety of MESO-XANTHIN F199® vs. a control saline solution containing hyaluronic acid of the same molecular weight and concentration. Preprinted forms were used by the subject for assessment of specific signs/symptoms at the sites of injections: Erythema, Swelling, Itching, Pain/Tenderness. Subjects rated each specific sign/symptom as mild, moderate, or severe for three weeks following the injections. All the specific signs/symptoms were present in the mild or moderate forms for the first three days in most subjects, up to 7 days in some of them, and very rarely in the severe form for more than seven days. No statistically significant differences in the specific signs/symptoms severity or duration were observed between MESO-XANTHIN F199® and the control solution.
MESO-XANTHIN F19 | (N=320) | n (%) | ||
Mild | Moderate | Severe | TOTAL | |
Erythema | 148 (46.3) | 71 (22.2) | 21 (6.6) | 240 (75.0) |
Swelling | 62 (19.4) | 14 (4.4) | 1 (0.3) | 77 (24.1) |
Itching | 24 (7.5) | 7 (2.2) | 2 (0.6) | 33 (10.3) |
Pain/Tenderness | 36 (11.3) | 8 (2.5) | 4 (1.3) | 48 (15.0) |
CONTROL | (N=320) | n (%) | ||
Mild | Moderate | Severe | TOTAL | |
Erythema | 141 (44.1) | 77 (24.1) | 24 (7.5) | 242 (75.6) |
Swelling | 60 (18.8) | 12 (3.8) | 3 (0.9) | 75 (23.4) |
Itching | 21 (6.6) | 9 (2.8) | 1 (0.3) | 31 (9.7) |
Pain/Tenderness | 33 (10.3) | 9 (2.8) | 2 (0.6) | 44 (13.8) |
Table 1. Treatment site responses in subjects after initial treatment.
MESO-XANTHIN F199 | (N=320) | n (%) | ||
1-3 Days | 4-7 Days | 8-14 Days | > 14 Days | |
Erythema | 231 (72.2) | 7 (2.2) | 2 (0.6) | 0 (0) |
Swelling | 68 (21.3) | 6 (1.9) | 3 (0.9) | 0 (0) |
Itching | 27 (8.4) | 5 (1.6) | 1 (0.3) | 0 (0) |
Pain/Tenderness | 37 (11.6) | 9 (2.8) | 2 (0.6) | 0 (0) |
CONTROL | (N=320) | n (%) | ||
1-3 Days | 4-7 Days | 8-14 Days | > 14 Days | |
Erythema | 234 (73.1) | 5 (1.6) | 3 (0.9) | 0 (0) |
Swelling | 63 (19.7) | 10 (3.1) | 2 (0.6) | 0 (0) |
Itching | 23 (7.2) | 6 (1.9) | 2 (0.6) | 0 (0) |
Pain/Tenderness | 31 (9.7) | 10 (3.1) | 3 (0.9) | 0 (0) |
Table 2. Duration of the treatment site responses in subjects after initial treatment.
MESO-XANTHIN F199® is supplied in a disposable glass syringe with LUER-LOK™ fitting (needle provided separately), packaged in a vac-formed tray with a Tyvek-film seal. Each packaged preparation contains a disposable one-time-use syringe filled with 1.5 mL of MESO-XANTHIN F199®, directions for use, and a label containing the following information: device name, syringe volume, lot number, and expiration date.
The provided label is affixed to the patient’s medical record and provides the physician with a medical history.
- Store away from sunlight at a temperature of 2 - 25°C.
- Do not freeze, reuse, or resterilize.
- The device must be used prior to the printed expiration date.
Proper assembly ensures the safe and accurate use of MESO-XANTHIN F199® —
- Hold firm around both the glass syringe barrel and at the cusp of the LUER-LOK adaptor using the thumb and forefinger.
- Proceed to grasp the needle shield with the other hand while pushing and rotating to ensure proper assembly.
- Examination of the patient’s medical history is advised to identify indications and contraindications for the use of soft-tissue injection solutions. Potential allergies can be identified by interviewing the patient and, if necessary, performing allergic and tissue sensitivity testing. Treatment shall be prescribed on the basis of indications and the patient’s age.
- Patients should avoid taking high doses of Vitamin A or E supplements, aspirin, or nonsteroidal anti-inflammatory medications prior to treatment, as these products may increase bleeding or bruising at the injection site(s).
- Do not expose the injection sites to severe cooling (wind, frost) shortly before treatment.
- Refrain from using any indoor tanning or sauna/steam baths shortly before treatment.
- Remove any makeup before the procedure.
- Treat the skin three times with a 0.05% chlorhexidine solution before administering MESO-XANTHIN F199®.
- The application of local anesthetic cream is permitted if required.
- Ensure that patients are properly counseled and that all potential risks, benefits, and expected outcomes are discussed.
- Assess the patient’s needs for pain management by utilizing the appropriate anesthetic treatment for managing comfort.
- The patient’s face should be washed and treated with alcohol or another suitable antiseptic solution.
- It is recommended to use sterile gloves during invasive procedures to ensure sterility.
- Upon injection, press the syringe rod until any pockets of air escape and a small droplet of the solution is visible at the tip.
- MESO-XANTHIN F199® is administered using a thin gauge needle (32G). The needle is introduced at an approximate angle of 45° parallel to the facial skin’s surface - 2-4 mm deep, 0.8-1 cm apart, and at 30° to the neck skin’s surface — 1-2 mm deep. Proper administration of Meso-Xanthin F199 consists of mid-dermis injections; care should be taken to avoid deep-dermis injections.
- Inject by applying equal pressure along the plunger rod; close attention must be paid to ensure the injection is halted just before the needle is removed from the skin to prevent material from protruding or being injected too superficially.
- Average use per treatment session is dependent on the injection site(s) as well as the amount of correction desired. Based on clinical observations, the maximum recommended dose per session is 1.5 mL per person.
🔻 DO NOT OVERCORRECT 🔻
MULTIPLE INTRADERMAL INJECTIONS
- Facial Skin: The needle is introduced at 45° to the skin surface — 2-4 mm deep, 0.8-1 cm apart;
- Neck Skin: The needle is introduced at 30° to the skin surface — 1-2 mm deep, needle bevel orientation does not matter.
MICRO-PAPULAR TECHNIQUE
- Periorbital Region: The needle bevel should be oriented upwards in order to improve control over the single injection; The papule diameter must not exceed 1 mm;
Recommended Needle — 32G (0.23 x 4mm)
ONE (1) 1.5 mL SYRINGE IS INTENDED TO TREAT THREE AREAS: THE FACE, NECK, & DÉCOLLETAGE. 33G (0.20 x 4mm) may be used without running the risk of uneven distribution.
CAUTION: Use of a needle larger than 30G may cause incorrect distribution. Deviation from these methods can lead to pronounced swelling of the treated area.
- Do not apply or use decorative cosmetics for 24 hours.
- Do not expose the injection sites to severe cooling, i.e., wind or frost.
- Refrain from using any indoor tanning or sauna/steam baths throughout the treatment procedures.
- Refraining from active sports or physical exercise for 48 hours, these stressors can cause temporary redness, swelling, or itching at the injection site(s).
- To report potential adverse effects, please promptly notify ABG LAB at 1-800-682-5741 or [email protected].
- MESO-XANTHIN F199® does not include a needle; use extreme caution to avoid sharps exposure. Ensure appropriate usage of referenced needle size.
- To help avoid needle breakage, do not attempt to straighten a bent needle. Discard it and complete the procedure with a replacement needle.
- Do not shield used needles. This practice should be avoided; discard unshielded needles in approved collectors.
- Follow all national, state, local, or institutional guidelines for using and disposing of sharp medical devices. Obtain prompt medical attention if an injury occurs.
Manufactured For
To place an order, please call 1-800-682-5741 or email [email protected].
12/2016 DFU.MX V2 [EN] © 2016 ABG LAB, LLC. All trademarks are the property of their respective owners.