What it is
Belotero Soft Lidocaine is an injectable, biodegradable implant of cross-linked sodium hyaluronate of non-animal origin, with 0.3% lidocaine hydrochloride. It is used to fill fine perioral lines.
Intended use (per instructions for use)
Indicated for injection into the upper and mid layers of the dermis for the treatment of fine perioral lines. According to the manufacturer's clinical data, the product has been shown to last for at least 6 months. The purpose of the product is purely aesthetic; no clinical benefits can be expected.
Composition
Sodium hyaluronate 20 mg/ml, lidocaine hydrochloride 3 mg/ml, phosphate buffer pH 7 q.s. 1 ml. Residual BDDE ≤ 2 ppm.
Treatment
- Contents: 1 pre-filled 1 ml syringe and 2 sterile single-use 30G½″ needles.
- Injection: upper and mid layers of the dermis. Inject slowly, aspirate before injecting and avoid overcorrection. Maximum 3 ml per session and 8 ml per year.
Important to know
For injection only by healthcare professionals with training and knowledge of the anatomy. Contraindicated in case of known hypersensitivity to the constituents (including sodium hyaluronate, BDDE, lidocaine or other amide-type local anaesthetics), in pregnant or breastfeeding women, under 18 years of age, in case of general infection and in active autoimmune disease. Do not inject into blood vessels, into skin with active inflammation or infection, into areas previously treated with a permanent skin filler, or into the glabella or nose area. Rare but serious events have been reported after unintentional injection into facial blood vessels (including vision impairment, blindness, stroke and skin necrosis). Single-use device; do not re-sterilise or reuse.
Storage and shelf life
Store at 2–25 °C, protected from light and dry. Avoid mechanical shocks. Do not freeze. Check the packaging and expiry date before use.
Documentation and traceability
CE-marked (CE 0123). Manufacturer: Anteis SA, Plan-les-Ouates, Switzerland. Authorised representative in the EU: Merz Aesthetics GmbH, Frankfurt am Main, Germany. See the attached Norwegian instructions for use (version 4.0, 23.02.2026).
