Topical local anaesthetic Pregnancy: Use in pregnant women should be undertaken with care because data are insufficient, although topical application is associated with only a low level of systemic absorption; animal studies do not indicate direct or indirect negative effects on pregnancy or foetal development. Lidocaine and prilocaine cross the placenta. Can be used during breast-feeding if clinically needed, as the quantities excreted into milk are very small (§4.6).

Lidocaine with prilocaine

Brand names: EMLA, Denela

Lidocaine with prilocaine is a fixed combination of two amide local anaesthetics formulated as a topical cream to produce surface anaesthesia of intact skin before minor procedures such as cannulation or superficial dermatological treatments.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Skin, minor procedures (e.g. needle insertion, surgical treatment of localised lesions): 2 g (approximately half a 5 g tube), or approximately 1.5 g per 10 cm2, applied for 1 to 5 hours

Route: Cutaneous — apply a thick layer of cream under an occlusive dressing (no occlusive dressing is required for procedures on genital mucosa)

Frequency: Single application before the procedure; the procedure should be commenced immediately after removal of the cream

Max: Dermal procedures on newly shaven skin of large body areas (e.g. laser hair removal, self-applied): maximum recommended dose 60 g, maximum recommended treated area 600 cm2, for a minimum of 1 hour and a maximum of 5 hours

eMC source: EMLA Cream 5% (lidocaine 2.5% with prilocaine 2.5%) — both components of this fixed combination are covered by the label. Application to genital mucosa, genital skin or leg ulcers should only be performed by or under the supervision of a healthcare professional. Other adult/adolescent (>=12 years) regimens from Table 1: dermal surgical procedures on larger areas in a hospital setting, e.g. split-skin grafting — approximately 1.5-2 g per 10 cm2 for 2 to 5 hours; skin of male genital organs prior to injection of local anaesthetics — 1 g per 10 cm2 for 15 minutes; skin of female genital organs prior to injection of local anaesthetics — 1-2 g per 10 cm2 for 60 minutes; genital mucosa (e.g. removal of genital warts, prior to injection of local anaesthetics) — approximately 5-10 g of cream for 5-10 minutes; prior to cervical curettage — 10 g in the lateral vaginal fornices for 10 minutes; leg ulcers (adults only) for mechanical cleansing/debridement — approximately 1-2 g per 10 cm2 up to a total of 10 g, applied for 30-60 minutes. Anaesthesia decreases after longer application times. Plasma concentrations have not been determined at doses above 10 g. In adolescents weighing less than 20 kg the maximum dose on genital mucosa should be proportionally reduced. In atopic dermatitis the application time should be reduced (15-30 minutes may suffice; 30 minutes prior to removal of mollusca). Paediatric dosing (Table 2) is by age band and area rather than per kg: minor procedures approximately 1 g per 10 cm2 for one hour — newborn infants and infants 0-2 months, up to 1 g and 10 cm2 for one hour with only one single dose in any 24-hour period; infants 3-11 months, up to 2 g and 20 cm2 for one hour; toddlers and children 1-5 years, up to 10 g and 100 cm2 for 1-5 hours; children 6-11 years, up to 20 g and 200 cm2 for 1-5 hours. From 3 months of age a maximum of 2 doses separated by at least 12 hours may be given in any 24-hour period. Must not be used at less than 37 weeks gestational age, and safety and efficacy on genital skin and genital mucosa have not been established under 12 years. No dose reduction is necessary in the elderly or in hepatic impairment. The openFDA record in this bundle is an unrelated US over-the-counter haemorrhoidal product and was not used.

Dose adjustments

Renal

A dose reduction is not necessary among patients with restricted renal function (§4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to lidocaine and/or prilocaine, to local anaesthetics of the amide type, or to any of the excipients (§4.3)

Side effects

Transient local application site reactions — erythema, oedema, pallor (common)
Burning sensation, application site pruritus and warmth (common/uncommon)
Methaemoglobinaemia (rare; more frequently observed in newborn infants and infants aged 0 to 12 months, often in connection with overdose)
Purpura and petechiae, especially after longer application times in children with atopic dermatitis or molluscum contagiosum (rare)
Hypersensitivity and, rarely, anaphylactic shock; corneal irritation and chemical burns to the eyes if eye contact occurs

Interactions

Patients treated with class III antiarrhythmics (e.g. amiodarone) should be carefully monitored and ECG monitoring considered, as cardiac effects may be additive (§4.4 — §4.5 was not retrieved in this bundle)
Should not be used in infants up to 12 months of age receiving treatment with methaemoglobin-inducing agents (§4.2/§4.4)
Lidocaine and prilocaine have bactericidal and antiviral properties above 0.5-2%, so the results of intracutaneous injections of live vaccines should be monitored (§4.4)

Clinical monograph

How it works

Both agents reversibly block voltage-gated sodium channels in cutaneous nerve endings, preventing nerve impulse conduction and producing localised numbing once absorbed through the skin.

Prescribing in practice

Prilocaine can cause methaemoglobinaemia, so avoid use in glucose-6-phosphate dehydrogenase deficiency and take particular care in young infants and with other methaemoglobinaemia-inducing drugs.
Apply under an occlusive dressing for the recommended time before the procedure and avoid application to broken skin, wounds, eyes or mucous membranes unless a suitable formulation is specified.
Avoid contact with the eyes as it may cause irritation and loss of protective reflexes.

Monitoring

Monitoring is clinical, observing for adequate anaesthesia, local reactions such as pallor or erythema, and — particularly in susceptible patients — signs of methaemoglobinaemia such as cyanosis.

Counselling the patient

Apply the cream and cover with the dressing for the full time advised before your procedure.
Temporary paleness, redness or mild swelling of the treated skin is normal.
Keep the cream away from the eyes and do not apply to broken skin.

Evidence & guidelines

Topical lidocaine with prilocaine is a long-established surface anaesthetic with well-characterised pharmacology described in its SPC and standard prescribing references.

Reference: NICE CG104; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways