What it is
Belotero Balance Lidocaine is an injectable, biodegradable implant of cross-linked sodium hyaluronate of non-animal origin, with 0.3% lidocaine hydrochloride. It is used for the treatment of facial wrinkles and folds and for volume enhancement.
Intended use (per instructions for use)
Indicated for injection from the epidermis to the dermis for the treatment of nasolabial folds, marionette lines, perioral lines, horizontal forehead lines and smile lines; for submucosal or subcutaneous injection for lip enhancement; and for injection in the supraperiosteal plane for filling the infraorbital foramen, including the tear troughs. Duration per indication is stated in the instructions for use. The purpose of the product is purely aesthetic; no clinical benefits can be expected.
Composition
Sodium hyaluronate 22.5 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 needles (1 × 27G½″ and 1 × 30G½″).
- Injection: see intended use. Inject slowly, aspirate before injecting and avoid overcorrection. Maximum 8.0 ml per session for the whole face and 16.0 ml per year; at least 2 weeks between injections at the same site.
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 5.0, 23.02.2026).
