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LMX4 Lidocaine 4% w/w Cream 5g

LMX4 Lidocaine 4% w/w Cream 5g

LMX4

Topical Anaesthetic
  • MHRA Licensed medicinal product in the UK (LMX4 Lidocaine 4% w/w Cream).
  • Conforms to applicable national requirements for over The Counter topical anaesthetic creams containing lidocaine.
Local Anaesthetic Numbing Cream

Description

LMX4 Cream (5g) is a 4% lidocaine topical anaesthetic cream used to numb intact skin before minor medical and cosmetic procedures involving needles or other potentially painful stimuli, such as blood tests, injections, vaccinations and certain dermatological or aesthetic treatments.

Bnefits

  • Provides effective topical anaesthesia of intact skin prior to superficial procedures such as venipuncture, IV cannulation and blood sampling.
  • Helps reduce pain and discomfort from needle procedures including injections, vaccinations and blood tests.
  • Can be used before minor medical and cosmetic skin procedures (e.g. laser treatments, dermal filler injections, tattoos and other aesthetic interventions) on intact skin when used in line with local guidance.
  • Contains 4% lidocaine in a liposomal cream base for enhanced penetration and rapid onset of action.
  • Non-invasive and easy to apply, offering a convenient alternative or adjunct to other pain-reduction strategies.
  • Available as a small 5g tube, suitable for occasional use and for numbing a small area of skin.

Indications

  • Topical anaesthesia of intact skin prior to insertion of IV catheters and blood sampling.
  • Topical anaesthesia prior to venipuncture, IV cannulation and similar needle procedures in adults and children where licensed.
  • Topical anaesthesia prior to administration of potentially painful topical treatments on larger areas of intact skin in adults.
  • Pain reduction for minor medical procedures on intact skin when a local topical anaesthetic is appropriate.
  • Supportive use in aesthetic and dermatological procedures on intact skin (e.g. laser hair removal, dermal injections, tattoos, microneedling) in line with professional and local regulatory guidance.

Composition

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

Formulation

  • Topical oil-in-water liposomal cream containing 4% w/w lidocaine.
  • Non-sterile, white to off-white smooth cream intended for application to intact skin.
  • Liposomal delivery system designed to enhance penetration of lidocaine into the epidermis and dermis.

Packaging

  • Aluminium tube containing 5 g of LMX4 Lidocaine 4% w/w Cream with screw cap.
  • Pack configurations may include single 5 g tubes or multipacks (e.g. healthcare supply packs) depending on distributor.
  • Supplied in an outer carton with patient information leaflet.

Usage

  • For external use on intact skin only; do not apply to broken, blistered or irritated skin and avoid contact with eyes, mouth, inside the nose or ears.
  • Adults and elderly (needle procedures): typically 1–2.5 g of cream applied to an area of approximately 2.5 cm x 2.5 cm at the intended needle site, as described in the patient information leaflet.
  • Adults 18 years and over (larger surface topical treatments on intact skin): 1.5–2 g per 10 cm², up to a maximum total area of approximately 900 cm², without exceeding the recommended total dose, following official product directions.
  • Apply a uniform layer of cream to the procedure area at least 30 minutes before the procedure; for some indications 30–60 minutes application time is recommended.
  • If advised, cover the applied cream with an occlusive dressing to prevent accidental removal and to optimise anaesthetic effect.
  • Shortly before the procedure, remove any dressing and thoroughly wipe off the cream with gauze or tissue.
  • Do not reapply to the same area for at least 12 hours after removal of the previous application when used for large-area topical anaesthesia as per adult dosing guidance.
  • Teleta listing advises use only in patients aged 18 years and over; always follow local labelling and professional guidance regarding age restrictions and dosing.
  • Wash hands after application unless the hands themselves are being treated.

Contraindications

  • Known hypersensitivity or allergy to lidocaine, other local anaesthetics of the amide type, or any of the excipients (including benzyl alcohol, propylene glycol or soy/lecithin components).
  • Do not use on broken, blistered, inflamed or eczematous skin, or on mucous membranes (e.g. inside mouth, nose, genital area) unless specifically directed by a healthcare professional and local labelling allows.
  • Do not use in or near the eyes; if accidental eye exposure occurs, rinse immediately with water or saline and protect the eye until normal sensation returns.
  • Use in very young infants has specific restrictions; the UK patient leaflet contraindicates use in infants under 1 month of age and imposes strict limits in infants and children. Use only according to the local product information and under appropriate medical supervision.
  • Caution in patients with severe hepatic dysfunction, certain cardiac conduction disturbances or those receiving other local anaesthetics or class I antiarrhythmics, due to potential additive systemic toxicity.
  • Caution or avoidance in individuals with known methaemoglobinaemia or predisposition to methaemoglobinaemia.

Adverse Effects

  • Common local reactions at the application site such as pallor or redness of the skin, slight swelling, initial burning or itching sensation.
  • Application-site irritation, dryness, tingling, or rash.
  • Less commonly, allergic reactions including contact dermatitis or urticaria.
  • Very rare but serious hypersensitivity reactions including angioedema or anaphylactoid reactions.
  • Systemic toxicity (e.g. central nervous system or cardiovascular symptoms) can occur if excessive amounts are used, large areas are treated, or the cream is applied to damaged skin or under inappropriate occlusion.
  • Methaemoglobinaemia has been reported rarely with topical local anaesthetics and is a theoretical risk, particularly in infants and in combination with other oxidising drugs.

Storage Conditions

  • Store at or below 25°C; excursions between 15–30°C are generally acceptable as per controlled room temperature guidance.
  • Do not freeze.
  • Keep the tube tightly closed when not in use and store in the original carton to protect from light.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the pack; discard any unused cream after the expiry date.

Duration

Single-application use per procedure; anaesthetic effect generally begins within 30 minutes and can persist for up to 1\u20132 hours after removal, depending on dose, application time and site.

Onset

Approximately 30 minutes after application (30\u201360 minutes with occlusion for maximum effect).

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