BioRePeelCl3 FND Face (5 x 6ml)

BioRePeelCl3 FND Face (5 x 6ml)

BioRePeel

Professional chemical peel (medical device)
  • CE Marked medical device under EU MDR 2017/745 for BioRePeelCl3 FND and BODY (first peeling in the aesthetic industry reported to achieve EU MDR CE mark).
  • Class III medical device classification in EU/EEA markets, with associated regulatory controls for professional use.
  • Manufactured by CMed Aesthetics, an ISO 13485 Certified medical device manufacturer.
  • Produced and quality Controlled in Italy in compliance with European medical device regulations.
  • Distributed only to qualified medical professionals and authorised aesthetic practitioners; some distributors require proof of professional status prior to supply.
Biphasic 35% TCA biostimulating peel for face, neck and d\u00e9collet\u00e9

Description

BioRePeelCl3 FND Face is an innovative, biphasic 35% TCA (trichloroacetic acid) medical peeling device developed by CMed Aesthetics for the treatment of the face, neck and décolleté. Classified as a topical Class III medical device, it combines an exfoliating, keratolytic action with powerful biostimulation and revitalisation. The hydrophilic yellow phase contains 35% TCA together with a blend of alpha-, beta- and poly-hydroxy acids, amino acids, vitamins and GABA, while the lipophilic blue phase protects the formulation from oxidation and provides filming and moisturising support. The peel removes dead corneocytes, cleans pores in depth and stimulates new collagen and elastin synthesis, making it suitable for fine lines, acne, fresh scars, hyperpigmentation and blocked pores. BioRePeelCl3 FND offers immediate visible improvement in skin tone and texture with little to no downtime and no frosting effect when used according to protocol.

Bnefits

  • Biostimulating peel that promotes new collagen and elastin formation while exfoliating damaged epidermal cells.
  • Deeply cleans and decongests pores, helping to treat acne, comedones and blocked pores.
  • Improves fine lines, early wrinkles and photo-aging signs on the face, neck and décolleté.
  • Evens skin tone and texture, helping with post-acne changes and mild hyperpigmentation.
  • Moisturising, antioxidant and revitalising effects from amino acids, vitamins and GABA.
  • Biphasic technology (lipophilic blue phase over hydrophilic yellow phase) limits oxidation and enhances safety and stability.
  • Instant visible results with little to no downtime and no classic TCA frosting when performed properly.
  • Suitable for use on face, neck, décolleté and delicate intimate zones under professional supervision.
  • Can be used all year round when combined with appropriate sun protection, due to its non-photosensitising profile.

Indications

  • Biorevitalisation and rejuvenation of face, neck and décolleté skin.
  • Fine lines and early wrinkles.
  • Photo-aging and texture changes from UV exposure and pollution.
  • Acne and comedonal acne, including prevention of new lesions (as an adjuvant treatment).
  • Post-acne and "fresh" superficial scarring.
  • Hyperkeratosis and thickened stratum corneum.
  • Enlarged pores and seborrhoeic/oily skin.
  • Dull, uneven skin tone and loss of elasticity.
  • Adjuvant treatment in prevention of acne scarring, as indicated by the manufacturer.

Composition

  • Trichloroacetic acid (TCA) 35% – main peeling and keratolytic agent.
  • Lactobionic acid – poly-hydroxy acid (PHA) providing gentle exfoliation and hydration.
  • Salicylic acid – beta-hydroxy acid (BHA) with comedolytic and keratolytic action, ideal for acne-prone skin.
  • Tartaric acid – alpha-hydroxy acid (AHA) contributing to exfoliation and brightening.
  • Citric acid – alpha-hydroxy acid (AHA) supporting exfoliation and antioxidant effect.
  • Gamma-aminobutyric acid (GABA) – lifting/relaxing agent with skin-smoothing action.
  • Glycine – amino acid involved in collagen synthesis and tissue repair.
  • Proline – amino acid important for collagen structure and dermal support.
  • Hydroxyproline – amino acid derivative associated with collagen stabilisation.
  • Arginine – amino acid that supports microcirculation and tissue repair.
  • Vitamin C (ascorbyl glucoside / sodium ascorbate) – antioxidant vitamin that helps protect against oxidative stress and supports collagen synthesis.
  • Vitamin B2 (riboflavin) – antioxidant vitamin that supports cellular metabolism.
  • Additional excipients and solvents constituting the hydrophilic and lipophilic phases (e.g. squalane, isopropyl myristate and stabilisers, as described for the line).

Formulation

  • Two-phase (biphasic) topical medical device peel.
  • Hydrophilic yellow phase containing 35% TCA, AHA/BHA/PHA acids, amino acids, vitamins and GABA.
  • Lipophilic blue phase that floats on the hydrophilic phase to mechanically protect TCA and other actives from oxidation, providing filming and moisturising action.
  • Topical solution applied with gloves or applicators; non-injectable and needle-free.
  • Acidic pH suitable for controlled chemical exfoliation under professional supervision.

Packaging

  • Box containing 5 ampoules/vials of 6 ml each (FND – Face, Neck, Décolleté).
  • Biphasic liquid visible as blue lipophilic phase over yellow hydrophilic phase.
  • Sterile butyl-stoppered vials designed to be shaken to form a temporary emulsion before use.
  • Professional packaging labelled as a Class III medical device for aesthetic/dermatological use.
  • For professional use only; supply generally restricted to qualified medical/aesthetic practitioners and clinics.

Usage

  • For professional use only; treatment must be carried out by trained, medically qualified or appropriately licensed aesthetic practitioners.
  • Cleanse the treatment area (face, neck, décolleté, or intimate area) thoroughly with appropriate degreasing/detersion products (e.g. acetone or surfactant cleansers) until the skin is oil-free.
  • Shake the vial/ampoule vigorously for a few seconds until the biphasic solution turns an even green shade, indicating a temporary emulsion.
  • Without removing the butyl stopper, draw up the required volume using a sterile syringe (typical amounts per protocol: face 1.5–2.0 ml; neck 1.0–1.5 ml; décolleté 2.0–2.5 ml).
  • Apply the product evenly to the treatment area using gloved fingers (nitrile gloves) or a sterile applicator/gauze, avoiding the eyes, mucous membranes and any broken skin.
  • Massage or spread the peel until it is evenly distributed; allow it to act for approximately 3–5 minutes on face, neck and décolleté, adjusting contact time to skin type and tolerance.
  • After the desired exposure time, remove the peel by wiping the area with gauze soaked in water, then rinse gently if required.
  • Apply a soothing, hydrating post-treatment serum (e.g. BioReHydra) and/or cream (e.g. BioReLift) and a broad-spectrum SPF.
  • Recommended treatment protocol for FND: every 7–12 days for a total of 4–6 sessions, depending on indication and clinical judgement.
  • Post-care: avoid direct sun exposure, heat (sauna, hot baths, intense exercise) and irritating topicals (retinoids, strong acids) for at least 24–48 hours; use gentle skincare and high-SPF sunscreen daily.
  • Do not use as a home/DIY peel; self-application is contraindicated due to the strength of the formulation.

Contraindications

  • Known hypersensitivity or allergy to trichloroacetic acid, salicylic acid, lactobionic acid, tartaric acid, citric acid, GABA, amino acids, vitamins or any excipient in the formulation.
  • Active skin infections (bacterial, viral or fungal) in the treatment area, including active herpes simplex lesions.
  • Open wounds, erosions, severe dermatitis or compromised skin barrier in the treatment area.
  • Severe inflammatory or autoimmune skin diseases in the area to be treated, unless cleared by a dermatologist.
  • History of abnormal wound healing or keloid formation in the treated regions.
  • Recent medium- or deep-depth chemical peels, ablative laser resurfacing or other aggressive skin procedures in the same area (within the time frame considered unsafe by the treating clinician).
  • Use of systemic isotretinoin within a period contraindicated by standard chemical peel guidelines (commonly within the previous 6–12 months, according to local protocols).
  • Pregnancy and breastfeeding are commonly considered relative or absolute contraindications; treatment should be avoided unless permitted under local regulations and risk assessment by a physician.
  • Known tendency to post-inflammatory hyperpigmentation without adequate photoprotection and risk counselling.

Adverse Effects

  • Transient erythema, warmth and tingling or burning sensation during and shortly after application.
  • Mild peeling, dryness or flaking of the treated skin over the following days, typically less intense than classic high-strength TCA peels when used correctly.
  • Tightness, mild oedema or sensitivity in the treated area.
  • Risk of post-inflammatory hyperpigmentation, particularly in darker skin phototypes or after inadequate sun protection.
  • Irritant or allergic contact dermatitis in susceptible individuals.
  • In rare cases, if misused or left too long, risk of superficial burns, prolonged erythema or textural changes; correct technique and adherence to protocol minimise this risk.
  • Potential reactivation of herpes simplex in predisposed patients if prophylaxis is not used when indicated.

Storage Conditions

  • Store unopened BioRePeelCl3 FND vials in a cool, dry place between approximately 2°C and 25°C, as advised by professional distributors.
  • Keep vials in their original box, protected from direct sunlight and excessive heat or humidity.
  • Ensure vials remain sealed and upright when not in use to avoid contamination and phase separation issues.
  • After first opening and partial use of a vial, many training/distributor guidelines allow storage at room temperature (up to about 25°C) or refrigerated (around 3–4°C) for up to 30 days, provided the vial is properly re-sealed and handled aseptically; always follow the latest manufacturer guidance and clinic protocol.
  • Do not freeze. Inspect each vial before use and discard if phase separation appears abnormal, colour changes markedly or contamination is suspected.
  • Keep out of reach of unauthorised personnel and patients; store in a controlled professional environment.

Duration

Contact time per session is typically 3\u20135 minutes on face, neck and d\u00e9collet\u00e9. A full course generally consists of 4\u20136 sessions performed every 7\u201312 days, with benefits from collagen stimulation and dermal remodelling persisting for weeks to months after completing the protocol, depending on skin condition and maintenance care.

Onset

Visible improvement in brightness, smoothness and hydration is usually immediate after the first session, with progressive reduction in fine lines, acne lesions, post-acne marks and textural irregularities over the course of 4\u20136 treatments.

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