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LMX4 Lidocaine 4% Cream 5g

LMX4 Lidocaine 4% Cream 5g

LMX4

Topical Anaesthetic
  • UK MHRA Licensed medicinal product (LMX4 Lidocaine 4% w/w Cream, PL 20685/0034).
  • Manufactured in accordance with EU/UK Good Manufacturing Practice (GMP) for medicinal products.
Local Anaesthetic Numbing Cream

Description

LMX4 Lidocaine 4% Cream 5g is a topical local anaesthetic cream containing 4% w/w lidocaine, used to numb intact skin before minor medical or aesthetic procedures such as venipuncture, injections, cannulation and other superficial skin procedures, helping to reduce pain and discomfort.

Bnefits

  • Provides effective numbing of intact skin prior to needle-based and other superficial procedures.
  • Contains 4% w/w lidocaine in a liposomal cream base for enhanced skin penetration and reliable topical anaesthesia.
  • Helps reduce pain and anxiety associated with blood tests, injections, vaccinations and cannulation.
  • Non-invasive, easy-to-apply alternative or adjunct to injectable local anaesthetics for minor procedures.
  • Small 5 g tube is convenient for occasional use and for numbing small, localised areas of skin.
  • Widely used in both medical and aesthetic practice as a pre-procedure topical anaesthetic.

Indications

  • Topical anaesthesia of intact skin prior to insertion of intravenous catheters (venous cannulation).
  • Topical anaesthesia prior to venipuncture or blood sampling.
  • Topical anaesthesia prior to other superficial skin procedures on intact skin where a local topical anaesthetic is appropriate.
  • Pain reduction before minor medical and aesthetic procedures involving needle insertion on intact skin, in accordance with local guidance.

Composition

  • Lidocaine 4% w/w (40 mg/g) as the active local anaesthetic.
  • Propylene glycol (75 mg/g) – excipient with known effect.
  • Benzyl alcohol (15 mg/g) – excipient with known effect.
  • Carbomer homopolymer type C.
  • Cholesterol.
  • Hydrogenated soy lecithin (phospholipon 80H).
  • Polysorbate 80.
  • Trometamol (trolamine).
  • Vitamin E acetate (alpha-tocopherol acetate).
  • Purified water.

Formulation

  • Topical oil-in-water liposomal cream containing 4% w/w lidocaine.
  • White to off-white smooth cream intended for application to intact skin.
  • Amide-type local anaesthetic preparation providing dermal analgesia by stabilising neuronal membranes.

Packaging

  • Aluminium tube containing 5 g LMX4 Lidocaine 4% w/w Cream with screw cap.
  • Tube supplied in an outer carton with patient information leaflet.
  • Licensed 5 g pack size suitable for single or limited multiple applications.

Usage

  • For cutaneous use on intact skin only; do not apply to broken, blistered, inflamed or eczematous skin.
  • Avoid contact with eyes, mouth, inside of nose or ears; if accidental eye contact occurs, rinse immediately with water or saline and protect the eye until sensation returns.
  • For needle procedures (e.g. venipuncture, cannulation): 1 g of cream is approximately equal to a 5 cm length from the 5 g tube.
  • Adults and children (per local product information): apply 1–2.5 g of cream over an area of about 2.5 cm × 2.5 cm at the intended site of needle insertion.
  • Apply in a thin, even layer to the skin; if required, cover with an occlusive dressing to prevent accidental removal and to optimise anaesthetic effect.
  • Allow approximately 30–60 minutes for adequate anaesthesia before starting the procedure; do not leave on for longer than the maximum time stated in the patient leaflet for the relevant age group.
  • Remove the cream and any dressing with gauze or tissue immediately before the procedure and prepare the skin as usual.
  • Do not reapply to the same area more frequently than recommended in the official product information, and observe a minimum 12-hour interval between large-area applications in adults.
  • Wash hands thoroughly after application unless the hands are being treated.

Contraindications

  • Hypersensitivity to lidocaine, other local anaesthetics of the amide type, or any of the excipients (including propylene glycol, benzyl alcohol or soy/lecithin components).
  • Use on broken, irritated, inflamed, blistered or eczematous skin.
  • Use on mucous membranes, in or near the eyes, inside the nose, mouth, ears or genital area unless specifically directed by a healthcare professional and allowed by local labelling.
  • Use in infants under 1 month of age (per product information), with strict precautions required in young infants and children.
  • Caution in patients with severe hepatic impairment, significant cardiac conduction disturbances, or those receiving other lidocaine-containing products or class I antiarrhythmic drugs due to risk of additive systemic toxicity.
  • Caution or avoidance in patients with congenital or idiopathic methaemoglobinaemia or in those receiving oxidising drugs that can induce methaemoglobinaemia.

Adverse Effects

  • Common, usually mild local skin reactions at the application site such as pallor, redness, slight swelling, initial burning or itching.
  • Application-site irritation, dryness, tingling or rash.
  • Less common allergic or hypersensitivity reactions including contact dermatitis or urticaria.
  • Very rare serious hypersensitivity reactions including angioedema and anaphylactoid reactions.
  • Systemic adverse effects related to lidocaine toxicity (e.g. dizziness, drowsiness, confusion, visual disturbances, tremor, convulsions, arrhythmias) if excessive amounts are used, large areas are treated, or the cream is applied to damaged skin or under inappropriate occlusion.
  • Rare risk of methaemoglobinaemia, particularly in infants or in combination with other oxidising medicinal products.

Storage Conditions

  • Store at or below 25°C in the original carton.
  • Do not freeze.
  • Keep the tube tightly closed when not in use.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the pack.

Duration

Single-application topical anaesthetic per procedure; typical application time 30\u201360 minutes with effect lasting up to 1\u20132 hours after removal depending on dose, site and occlusion.

Onset

Approximately 30 minutes after application to intact skin (30\u201360 minutes for maximum dermal anaesthesia, particularly under occlusion).

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