Medicine guide

Lidocaine and Prilocaine

25 mg/g + 25 mg/g · Cream

Prescription only
Amide Local Anesthetic

Active substance: Lidocaine and Prilocaine
Used in: Pain, sleep, mood, epilepsy and the brain
Made by: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-01-28

What it is

Amide Local Anesthetic

Used for

- normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.

The label’s usual adult dose

For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams (1/2 the 5 g tube) of lidocaine and prilocaine cream, 2.5%/2.5% over 20 to 25 cm 2 of skin surface for at least 1 hour.

Full directions ↓

Do not take it if

Lidocaine and prilocaine cream, 2.5%/2.5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

12other products contain Lidocaine and Prilocaine — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Lidocaine and prilocaine cream, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:

normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.
Lidocaine and prilocaine cream, 2.5%/2.5% is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS ).

From the official label · 2026-01-28 · DailyMed

How it works

From this product’s own US prescribing label.

Lidocaine and prilocaine cream, 2.5%/2.5%, applied to intact skin under occlusive dressing, provides dermal analgesia by the release of lidocaine and prilocaine from the cream into the epidermal and dermal layers of the skin and by the accumulation of lidocaine and prilocaine in the vicinity of dermal pain receptors and nerve endings.
Lidocaine and prilocaine are amide-type local anesthetic agents.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-28

Do not take it if

Lidocaine and prilocaine cream, 2.5%/2.5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Adult Patients-Intact Skin A thick layer of lidocaine and prilocaine cream, 2.5%/2.5% is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION ).
Minor Dermal Procedures:
For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams (1/2 the 5 g tube) of lidocaine and prilocaine cream, 2.5%/2.5% over 20 to 25 cm 2 of skin surface for at least 1 hour.
In controlled clinical trials using lidocaine and prilocaine cream, 2.5%/2.5%, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures:
For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream, 2.5%/2.5% per 10 cm 2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin:
As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream, 2.5%/2.5% (1 g/10 cm 2 ) to the skin surface for 15 minutes.
Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream, 2.5%/2.5%.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream.
The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2 , ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous Membranes For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream, 2.5%/2.5% for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place.
Patients should be lying down during the lidocaine and prilocaine cream, 2.5%/2.5% application, especially if no occlusion is used.
The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream, 2.5%/2.5%.
Pediatric Patients-Intact Skin The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream, 2.5%/2.5% based on a child's age and weight:
Age and Body Weight Requirements Maximum Total Dose of Lidocaine and Prilocaine Cream, 2.5%/2.5% Maximum Application Area Maximum Application Time 0 up to 3 months or < 5 kg 1g 10 cm 2 1 hour 3 up to 12 months and >5 kg 2g 20 cm 2 4 hours 1 to 6 years and >10 kg 10g 100 cm 2 4 hours 7 to 12 years and >20 kg 20g 200 cm 2 4 hours Please note:
If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream, 2.5%/2.5% should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION ).
Practitioners should carefully instruct caregivers to
avoid application of excessive amounts of lidocaine and prilocaine cream, 2.5%/2.5% (see PRECAUTIONS ).
When applying lidocaine and prilocaine cream, 2.5%/2.5% to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream, 2.5%/2.5% or the occlusive dressing.
A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine and prilocaine cream, 2.5%/2.5% should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS ).
When lidocaine and prilocaine cream, 2.5%/2.5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose ).
The amount absorbed in the case of lidocaine and prilocaine cream, 2.5%/2.5% is determined by the area over which it is applied and the duration of application under occlusion (see Table 2 , ** footnote , in Individualization of Dose ).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream, 2.5%/2.5% is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours.
The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose ).

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Application of lidocaine and prilocaine cream, 2.5%/2.5% to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine and prilocaine resulting in serious adverse effects (see Individualization of Dose ).
Patients treated with class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide) should be under close surveillance and ECG monitoring considered, because cardiac effects may be additive.
Studies in laboratory animals (guinea pigs) have shown that lidocaine and prilocaine cream, 2.5%/2.5% has an ototoxic effect when instilled into the middle ear.
In these same studies, animals exposed to lidocaine and prilocaine cream, 2.5%/2.5% only in the external auditory canal, showed no abnormality.
Lidocaine and prilocaine cream, 2.5%/2.5% should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible.
Methemoglobinemia:
Cases of methemoglobinemia have been reported in association with local anesthetic use.
Although all patients are at risk for methemoglobinemia, patients with glucose- 6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition.
If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.
Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood.
Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death.
Discontinue lidocaine and prilocaine cream, 2.5%/2.5% and any other oxidizing agents.
Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration.
A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
General:
Repeated doses of lidocaine and prilocaine cream, 2.5%/2.5% may increase blood levels of lidocaine and prilocaine.
Lidocaine and prilocaine cream, 2.5%/2.5% should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and prilocaine including acutely ill, debilitated, or elderly patients.
Lidocaine and prilocaine cream, 2.5%/2.5% should not be applied to open wounds.
Care should be taken not to allow lidocaine and prilocaine cream, 2.5%/2.5% to come in contact with the eye because animal studies have demonstrated severe eye irritation.
Also the loss of protective reflexes can permit corneal irritation and potential abrasion.
Absorption of lidocaine and prilocaine cream, 2.5%/2.5% in conjunctival tissues has not been determined.
If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine, however, lidocaine and prilocaine cream, 2.5%/2.5% should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine and prilocaine.
Lidocaine and prilocaine have been shown to inhibit viral and bacterial growth.
The effect of lidocaine and prilocaine cream, 2.5%/2.5% on intradermal injections of live vaccines has not been determined.
Information for Patients:
Drug Interactions:
Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis :
Long-term studies in animals designed to evaluate the carcinogenic potential of lidocaine and prilocaine have not been conducted.
Metabolites of prilocaine have been shown to be carcinogenic in laboratory animals.
In the animal studies reported below, doses or blood levels are compared with the Single Dermal Administration (SDA) of 60 g of lidocaine and prilocaine cream, 2.5%/2.5% to 400 cm 2 for 3 hours to a small person (50 kg).
The typical application of lidocaine and prilocaine cream, 2.5%/2.5% for one or two treatments for venipuncture sites (2.5 or 5 g) would be 1/24 or 1/12 of that dose in an adult or about the same mg/kg dose in an infant.
Chronic oral toxicity studies of ortho -toluidine, a metabolite of prilocaine, in mice (450 to 7200 mg/m 2 ; 60 to 960 times SDA) and rats (900 to 4,800 mg/m 2 ; 60 to 320 times SDA) have shown that ortho -toluidine is a carcinogen in both species.
The tumors included hepatocarcinomas/adenomas in female mice, multiple occurrences of hemangiosarcomas/ hemangiomas in both sexes of mice, sarcomas of multiple organs, transitional-cell carcinomas/ papillomas of urinary bladder in both sexes of rats, subcutaneous fibromas/fibrosarcomas and mesotheliomas in male rats, and mammary gland fibroadenomas/adenomas in female rats.
The lowest dose tested (450 mg/m 2 in mice, 900 mg/m 2 in rats; 60 times SDA) was carcinogenic in both species.
Thus the no-effect dose must be less than 60 times SDA.
The animal studies were conducted at 150 to 2,400 mg/kg in mice and at 150 to 800 mg/kg in rats.
The dosages have been converted to mg/m 2 for the SDA calculations above.
Mutagenesis:
The mutagenic potential of lidocaine HCl has been tested in a bacterial reverse (Ames) assay in Salmonella, an in vitro chromosomal aberration assay using human lymphocytes and in an in vivo micronucleus test in mice.
There was no indication of mutagenicity or structural damage to chromosomes in these tests.
Ortho -toluidine, a metabolite of prilocaine, at a concentration of 0.5 mcg/mL, was genotoxic in Escherichia coli DNA repair and phage-induction assays.
Urine concentrates from rats treated with ortho -toluidine (300 mg/kg orally; 300 times SDA) were mutagenic when examined in Salmonella typhimurium in the presence of metabolic activation.
Several other tests on ortho -toluidine, including reverse mutations in five different Salmonella typhimurium strains in the presence or absence of metabolic activation and a study to detect single strand breaks in DNA of V79 Chinese hamster cells, were negative.
Impairment of Fertility : See Use in Pregnancy .
Use in Pregnancy:
Teratogenic Effects:
Reproduction studies with lidocaine have been performed in rats and have revealed no evidence of harm to the fetus (30 mg/kg subcutaneously; 22 times SDA).
Reproduction studies with prilocaine have been performed in rats and have revealed no evidence of impaired fertility or harm to the fetus (300 mg/kg intramuscularly; 188 times SDA).
There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, lidocaine and prilocaine cream, 2.5%/2.5% should be used during pregnancy only if clearly needed.
Reproduction studies have been performed in rats receiving subcutaneous administration of an aqueous mixture containing lidocaine HCl and prilocaine HCl at 1:1 (w/w).
At 40 mg/kg each, a dose equivalent to 29 times SDA lidocaine and 25 times SDA prilocaine, no teratogenic, embryotoxic or fetotoxic effects were observed.
Labor and Delivery:
Neither lidocaine nor prilocaine are contraindicated in labor and delivery.
Nursing Mothers: Lidocaine, and probably prilocaine, are excreted in human milk.
Pediatric Use:
adults.
Geriatric Use Of the total number of patients in clinical studies of lidocaine and prilocaine cream, 2.5%/2.5%, 180 were age 65 to 74 and 138 were 75 and over.
General:
Repeated doses of lidocaine and prilocaine cream, 2.5%/2.5% may increase blood levels of lidocaine and prilocaine.
Lidocaine and prilocaine cream, 2.5%/2.5% should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and prilocaine including acutely ill, debilitated, or elderly patients.
Lidocaine and prilocaine cream, 2.5%/2.5% should not be applied to open wounds.
Care should be taken not to allow lidocaine and prilocaine cream, 2.5%/2.5% to come in contact with the eye because animal studies have demonstrated severe eye irritation.
Also the loss of protective reflexes can permit corneal irritation and potential abrasion.
Absorption of lidocaine and prilocaine cream, 2.5%/2.5% in conjunctival tissues has not been determined.
If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine, however, lidocaine and prilocaine cream, 2.5%/2.5% should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine and prilocaine.
Lidocaine and prilocaine have been shown to inhibit viral and bacterial growth.
The effect of lidocaine and prilocaine cream, 2.5%/2.5% on intradermal injections of live vaccines has not been determined.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Lidocaine, and probably prilocaine, are excreted in human milk.
Therefore, caution should be exercised when lidocaine and prilocaine cream, 2.5%/2.5% is administered to a nursing mother since the milk:plasma ratio of lidocaine is 0.4 and is not determined for prilocaine.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Lidocaine and prilocaine cream, 2.5%/2.5% should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics:
Examples of Drugs Associated with Methemoglobinemia:
Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see WARNINGS ).
Should lidocaine and prilocaine cream, 2.5%/2.5% be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Peak blood levels following a 60 g application to 400 cm 2 of intact skin for 3 hours are 0.05 to 0.16 mcg/mL for lidocaine and 0.02 to 0.10 mcg/mL for prilocaine.
Toxic levels of lidocaine (>5 mcg/mL) and/or prilocaine (>6 mcg/mL) cause decreases in cardiac output, total peripheral resistance and mean arterial pressure.
These changes may be attributable to direct depressant effects of these local anesthetic agents on the cardiovascular system.
In the absence of massive topical overdose or oral ingestion, evaluation should include evaluation of other etiologies for the clinical effects or overdosage from other sources of lidocaine, prilocaine or other local anesthetics.
Consult the package inserts for parenteral Xylocaine (lidocaine HCl) or Citanest (prilocaine HCl) for further information for the management of overdose.

Quoted from the official label, section “Overdosage”.

Use in children

Controlled studies of lidocaine and prilocaine cream, 2.5%/2.5% in
children under the age of seven years have shown less overall benefit than in older children or
adults.
These results illustrate the importance of emotional and psychological support of younger children undergoing medical or surgical procedures.
Lidocaine and prilocaine cream, 2.5%/2.5% should be used with care in patients with conditions or therapy associated with methemoglobinemia (see Methemoglobinemia subsection of WARNINGS ) .
When using lidocaine and prilocaine cream, 2.5%/2.5% in young children, especially infants under the age of 3 months, care must be taken to insure that the caregiver understands the need to limit the dose and area of application, and to prevent accidental ingestion (see DOSAGE AND ADMINISTRATION and Methemoglobinemia ).
In neonates (minimum gestation age:
37 weeks) and children weighing less than 20 kg, the area and duration of application should be limited ( see TABLE 2 in Individualization of Dose).
Studies have not demonstrated the efficacy of lidocaine and prilocaine cream, 2.5%/2.5% for heel lancing in neonates.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Of the total number of patients in clinical studies of lidocaine and prilocaine cream, 2.5%/2.5%, 180 were age 65 to 74 and 138 were 75 and over.
No overall differences in safety or efficacy were observed between these patients and younger patients.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Plasma levels of lidocaine and prilocaine in geriatric and non-geriatric patients following application of a thick layer of lidocaine and prilocaine cream, 2.5%/2.5% are very low and well below potentially toxic levels.
However, there are no sufficient data to evaluate quantitative differences in systemic plasma levels of lidocaine and prilocaine between geriatric and non-geriatric patients following application of lidocaine and prilocaine cream, 2.5%/2.5%.
Consideration should be given for those elderly patients who have enhanced sensitivity to systemic absorption (see PRECAUTION S ).
After intravenous dosing, the elimination half-life of lidocaine is significantly longer in elderly patients (2.5 hours) than in younger patients (1.5 hours).
(See CLINICAL PHARMACOLOGY ).

Quoted from the official label, section “Geriatric Use”.

Side effects

Localized Reactions:
During or immediately after treatment with lidocaine and prilocaine cream, 2.5%/2.5% on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.
Rare cases of discrete purpuric or petechial reactions at the application site have been reported.
Rare cases of hyperpigmentation following the use of lidocaine and prilocaine cream, 2.5%/2.5% have been reported.
The relationship to lidocaine and prilocaine cream, 2.5%/2.5% or the underlying procedure has not been established.
In clinical studies on intact skin involving over 1,300 lidocaine and prilocaine cream, 2.5%/2.5%-treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 or 2 hours.
There were no serious reactions that were ascribed to lidocaine and prilocaine cream, 2.5%/2.5%.
Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision.
Both neonates received 1.0 g of lidocaine and prilocaine cream, 2.5%/2.5%.
In patients treated with lidocaine and prilocaine cream, 2.5%/2.5% on intact skin, local effects observed in the trials included:
paleness (pallor or blanching) 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%.
In clinical studies on genital mucous membranes involving 378 lidocaine and prilocaine cream, 2.5%/2.5%-treated patients, one or more application site reactions, usually mild and transient, were noted in 41% of patients.
The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).
Allergic Reactions:
Allergic and anaphylactoid reactions associated with lidocaine or prilocaine can occur.
They are characterized by urticaria, angioedema, bronchospasm, and shock.
If they occur they should be managed by conventional means.
The detection of sensitivity by skin testing is of doubtful value.
Systemic (Dose Related) Reactions:
Systemic adverse reactions following appropriate use of lidocaine and prilocaine cream, 2.5%/2.5% are unlikely due to the small dose absorbed (see Pharmacokinetics subsection of CLINICAL PHARMACOLOGY ).
Systemic adverse effects of lidocaine and/or prilocaine are similar in nature to those observed with other amide local anesthetic agents including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest).
Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness.
Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly.
Advise patients or caregivers to
stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms:
pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.
When lidocaine and prilocaine cream, 2.5%/2.5% is used, the patient should be aware that the production of dermal analgesia may be accompanied by the block of all sensations in the treated skin.
For this reason, the patient should
avoid inadvertent trauma to the treated area by scratching, rubbing, or exposure to extreme hot or cold temperatures until complete sensation has returned.
Lidocaine and prilocaine cream, 2.5%/2.5% should not be applied near the eyes or on open wounds.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

Lidocaine and prilocaine cream, 2.5%/2.5% is supplied as follows:
NDC 0168-0357-30 30 gram tube, with a child-resistant cap NDC 0168-0357-55 5 gram tube, FOR HOSPITAL USE ONLY NDC 0168-0357-56 5 gram tube, with 12 dressings, FOR HOSPITAL USE ONLY NOT FOR OPHTHALMIC USE.
KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.
KEEP OUT OF THE REACH OF CHILDREN.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
E.
FOUGERA & CO.
A division of Fougera PHARMACEUTICALS INC.
Melville, New York 11747 Revised: 01/2024

Quoted from the official label, section “How Supplied”.

What is in it

Lidocaine and prilocaine cream, 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight.
This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals.
It is packaged in 30 gram tubes and 5 gram tubes for hospital use.
Lidocaine is chemically designated as acetamide, 2-(diethylamino)- N -(2,6-dimethylphenyl), has an octanol:
water partition ratio of 43 at pH 7.4, and has the following structure:
Prilocaine is chemically designated as propanamide, N -(2-methylphenyl)-2-(propylamino), has an octanol:
water partition ratio of 25 at pH 7.4, and has the following structure:
Each gram of lidocaine and prilocaine cream, 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carbomer 934P (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water.
Lidocaine and prilocaine cream, 2.5%/2.5% contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH.
The specific gravity of lidocaine and prilocaine cream, 2.5%/2.5% is approximately 1.00.
Structural Formula Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made by	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Active substance	Lidocaine and Prilocaine
Used in	Pain, sleep, mood, epilepsy and the brain
Strength	25 mg/g + 25 mg/g
Form	Cream
Route	Topical
Packs	1 TUBE in 1 CARTON / 30 g in 1 TUBE · 1 TUBE in 1 CARTON / 5 g in 1 TUBE
NDC	0168-0357

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

11 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Cream11 products
- 25 mg/g + 25 mg/g11
  25 mg/g + 25 mg/g · 11 companies
  - A-S Medication Solutions
  - Alembic Pharmaceuticals Inc.
  - Alembic Pharmaceuticals Limited
  - Bryant Ranch Prepack
  - E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC · this page
  - NuCare Pharamceuticals,Inc.
  - NuCare Pharmaceuticals, Inc.
  - Padagis US LLC
  +3 more

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Lidocaine and Prilocaine