ENNLA 5% CREAM 30G

Indications

Off-Label Uses

Off-label: analgesia before cosmetic procedures (e.g., laser hair removal/tattooing) and other minor painful skin procedures; premature ejaculation products exist but genital use for this purpose is off-label and carries systemic absorption risk.

Dosage & Administration

Maintenance Dose

Single application per procedure; not intended for repeated daily dosing

Side Effects

Common Side Effects

Application-site reactions such as pallor (blanching), erythema, edema, burning/stinging, pruritus; may also cause altered temperature sensation or numbness at the site.

Safety & Warnings

Warnings & Precautions

Key warnings/precautions: risk of methemoglobinemia (higher risk in infants <12 months, G6PD deficiency, and with methemoglobin-inducing drugs); use the minimum effective dose and shortest application time; avoid eyes; avoid use in ear canal if tympanic membrane perforation suspected; avoid/limit use on broken, inflamed, or large areas of skin unless directed; caution in severe hepatic or renal impairment and when used with other local anesthetics/antiarrhythmics.

Age Restriction

Avoid use in preterm neonates (gestational age <37 weeks). Use with caution in infants <12 months; avoid/limit use if receiving methemoglobin-inducing drugs.

Drug Interactions

Food Interaction

No clinically relevant food interactions (not applicable for topical use).

Storage & Patient Advice

Patient Counseling

Apply a thick layer to intact skin without rubbing, cover with an occlusive dressing, and leave for at least 60 minutes (follow procedure-specific instructions); remove completely before the procedure. Avoid eyes/ears and do not use on broken, inflamed, or infected skin unless specifically directed. Wash hands after use and protect the numbed area from heat/trauma. Seek urgent care for signs of methemoglobinemia (gray/blue/pale skin or lips, shortness of breath, fatigue), especially in infants/young children or with excessive dose/time.

Monitoring Requirements

No routine monitoring for typical use; in neonates/infants (especially ≤3 months) or other high-risk patients, monitor clinically for methemoglobinemia (e.g., cyanosis, gray/pale skin, dyspnea, fatigue) and consider methemoglobin measurement if symptomatic.

Pharmacology

Mechanism of Action

Lidocaine and prilocaine reversibly block voltage-gated sodium channels in neuronal membranes, inhibiting initiation and conduction of nerve impulses to produce local anesthesia.

Onset of Action

Intact skin (with occlusion): apply 60 minutes before procedure (may require up to 120 minutes for maximal effect). Genital mucosa: ~5-10 minutes.

Duration of Effect

After removal, anesthesia typically persists for about 1-2 hours.

Bioavailability

Variable; generally low with intact skin and recommended use, but increases with larger dose/surface area, longer application time, occlusion, or broken/inflamed skin. Estimated systemic bioavailability is typically <10% with intact skin under usual conditions and may approach ~20% with occlusion/large-area application.

Excretion

Primarily renal excretion of metabolites; only a small fraction is excreted unchanged in urine.

Product Information

Available Dosage Forms

Cream (this SFDA-registered product).

Composition per Dose

Each gram of cream: Lidocaine hydrochloride 25 mg + Prilocaine 25 mg

Skin Condition

Local Anesthesia

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