Lidocaine and Prilocaine 25 mg/g; 25 mg/g Cream
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antiarrhythmic class.
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🏭 Manufacturer & labeler
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.221 | $6.63 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $0.4392 | $13.18 / 30 g |
| Medicare drug plans payPart D · Q2 2026 | $0.3852 | $11.56 / 30 g |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lidocaine and Prilocaine 25 mg/g; 25 mg/gthis 00121-1002-30 | PAI | 1 tube | $0.221 | — | Discontinued | — |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 00168-0357-30 | E. | 1 tube | $0.221 | AB | Availability likely | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 00574-2042-30 | Padagis | 1 tube | $0.221 | AB | Availability likely | — |
| Lidocaine And Prilocaine Lidocaine And Prilocaine 25 mg/g; 25 mg/g 21922-0076-05 | Encube | 1 tube | $0.221 | AB | Availability likely | — |
| Lidocaine and prilocaine 25 mg/g; 25 mg/g 72578-0165-06 | Viona | 1 tube | $0.221 | AB | Availability likely | — |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 62332-0582-04 | Alembic | 1 tube | $1.335 | AB | Availability likely | +504% |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 46708-0582-04 | Alembic | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 50090-6589-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 63629-9604-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 68071-1625-03 | NuCare | 30 g | — | — | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 68071-3856-03 | NuCare | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 68788-4090-03 | Preferred | 1 tube | — | AB | FDA listed | — |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 68788-8150-03 | Preferred | 1 tube | — | AB | FDA listed | — |
| Lidocaine and prilocaine 25 mg/g; 25 mg/g 70771-1872-02 | Zydus | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 71335-2716-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 71335-2970-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 72162-1125-03 | Bryant | 1 tube | — | AB | FDA listed | — |
| Cadira Compliant Blood Stat 25 mg/g; 25 mg/g 76420-0313-01 | Asclemed | 1 tube | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00121-1002-30 You're viewing this | 1 TUBE in 1 CARTON (0121-1002-30) / 30 g in 1 TUBE | 2025-02-06 | Discontinued by firm |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Lidocaine and Prilocaine Cream USP, 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 effect observed in animal studies (see WARNINGS ).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Adult Patients-Intact Skin A thick layer of Lidocaine and Prilocaine Cream USP, 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 of Lidocaine and Prilocaine Cream USP, 2.5%/2.5% (1/2 the 5 g tube) over 20 to 25 cm 2 of skin surface for at least 1 hour. In controlled clinical trials using Lidocaine and Prilocaine Cream USP, 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 USP, 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 USP, 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 USP, 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 acuminate, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of Lidocaine and Prilocaine Cream USP, 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 USP, 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 USP, 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 USP, 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 USP, 2.5%/2.5% Maximum Application Area Maximum Application Time 0 up to 3 months or < 5 kg 1 g 10 cm 2 1 hour 3 up to 12 months and >5 kg 2 g 20 cm 2 4 hours 1 to 6 years and > 10 kg 10 g 100 cm 2 4 hours 7 to 12 years and > 20 kg 20 g 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 USP, 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 USP, 2.5%/2.5% (see PRECAUTIONS ). When applying Lidocaine and Prilocaine Cream USP, 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 USP, 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 USP, 2.5%/2.5% is used concomitantly with other produ…
⛔ Contraindications ▾
CONTRAINDICATIONS 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.
⚠️ Warnings ▾
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 (eg, 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 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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. To report SUSPECTED ADVERSE REACTIONS , contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
Drug Interactions 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 (eg, 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.
🤰 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.
🧒 Pediatric Use ▾
Pediatric Use 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.
🧓 Geriatric Use ▾
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. 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 PRECAUTIONS ).
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 ).
🆘 Overdosage ▾
OVERDOSAGE Peak blood levels following a 60 g application to 400 cm 2 of intact skin for 3 hours are 0.05 to 0.16 µg/mL for lidocaine and 0.02 to 0.10 µg/mL for prilocaine. Toxic levels of lidocaine (>5 µg/mL) and/or prilocaine (>6 µg/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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action 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. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
The onset, depth and duration of dermal analgesia on intact skin provided by lidocaine and prilocaine cream, 2.5%/2.5% depend primarily on the duration of application. To provide sufficient analgesia for clinical procedures such as intravenous catheter placement and venipuncture, lidocaine and prilocaine cream, 2.5%/2.5% should be applied under an occlusive dressing for at least 1 hour. To provide dermal analgesia for clinical procedures such as split- skin graft harvesting, lidocaine and prilocaine cream, 2.5%/2.5% should be applied under occlusive dressing for at least 2 hours.
Satisfactory dermal analgesia is achieved 1 hour after application, reaches maximum at 2 to 3 hours, and persists for 1 to 2 hours after removal. Absorption from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of lidocaine and prilocaine cream, 2.5%/2.5% to female genital mucosa, the average duration of effective analgesia to an argon laser stimulus (which produced a sharp pricking pain) was 15 to 20 minutes (individual variation in the range of 5 to 45 minutes).
Dermal application of lidocaine and prilocaine cream, 2.5%/2.5% may cause a transient, local blanching followed by a transient, local redress or erythema. Pharmacokinetics Lidocaine and prilocaine cream, 2.5%/2.5% is a eutectic mixture of lidocaine 2.5% and prilocaine 2.5% formulated as an oil in water emulsion. In this eutectic mixture, both anesthetics are liquid at room temperature (see DESCRIPTION ) and the penetration and subsequent systemic absorption of both prilocaine and lidocaine are enhanced over that which would be seen if each component in crystalline form was applied separately as a 2.5% topical cream.
Absorption : The amount of lidocaine and prilocaine systemically absorbed from lidocaine and prilocaine cream, 2.5%/2.5% is directly related to both the duration of application and to the area over which it is applied. In two pharmacokinetic studies, 60 g of lidocaine and prilocaine cream, 2.5%/2.5% (1.5 g lidocaine and 1.5 g prilocaine) was applied to 400 cm 2 of intact skin on the lateral thigh and then covered by an occlusive dressing. The subjects were then randomized such that one-half of the subjects had the occlusive dressing and residual cream removed after 3 hours, while the remainder left the dressing in place for 24 hours.
The results from these studies are summarized below. When 60 g of lidocaine and prilocaine cream, 2.5%/2.5% was applied over 400 cm 2 for 24 hours, peak blood levels of lidocaine are approximately 1/20 the systemic toxic level. Likewise, the maximum prilocaine level is about 1/36 the toxic level.
In a pharmacokinetic study, lidocaine and prilocaine cream, 2.5%/2.5% was applied to penile skin in 20 adult male patients in doses ranging from 0.5 g to 3.3 g for 15 minutes. Plasma concentrations of lidocaine and prilocaine following lidocaine and prilocaine cream, 2.5%/2.5% application in this study were consistently low (2.5 to 16 ng/mL for lidocaine and 2.5 to 7 ng/mL for prilocaine). The application of lidocaine and prilocaine cream, 2.5%/2.5% to broken or inflamed skin, or to 2,000 cm 2 or more of skin where more of both anesthetics are absorbed, could result in higher plasma levels that could, in susceptible individuals, produce…
🧬 Mechanism of Action ▾
Mechanism of Action 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. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
The onset, depth and duration of dermal analgesia on intact skin provided by lidocaine and prilocaine cream, 2.5%/2.5% depend primarily on the duration of application. To provide sufficient analgesia for clinical procedures such as intravenous catheter placement and venipuncture, lidocaine and prilocaine cream, 2.5%/2.5% should be applied under an occlusive dressing for at least 1 hour. To provide dermal analgesia for clinical procedures such as split- skin graft harvesting, lidocaine and prilocaine cream, 2.5%/2.5% should be applied under occlusive dressing for at least 2 hours.
Satisfactory dermal analgesia is achieved 1 hour after application, reaches maximum at 2 to 3 hours, and persists for 1 to 2 hours after removal. Absorption from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of lidocaine and prilocaine cream, 2.5%/2.5% to female genital mucosa, the average duration of effective analgesia to an argon laser stimulus (which produced a sharp pricking pain) was 15 to 20 minutes (individual variation in the range of 5 to 45 minutes).
Dermal application of lidocaine and prilocaine cream, 2.5%/2.5% may cause a transient, local blanching followed by a transient, local redress or erythema.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Lidocaine and Prilocaine Cream USP, 2.5%/2.5% is a white to off-white cream supplied as the following: NDC 0121-1002-30 30 gram tube (in a child resistant tube) NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do Not Freeze. DISTRIBUTED BY PAI Pharma Greenville, SC 29605 www.paipharma.com Rev. 03/25 I10020325
📦 Storage and Handling ▾
NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do Not Freeze. DISTRIBUTED BY PAI Pharma Greenville, SC 29605 www.paipharma.com Rev. 03/25 I10020325
📋 Description ▾
DESCRIPTION Lidocaine and Prilocaine Cream USP, 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.
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 USP, 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, PEG-60 Hydrogenated Castor oil (as emulsifiers), carbomer homopolymer type B, sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram.
Lidocaine and Prilocaine Cream USP, 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 USP, 2.5%/2.5% is 1.00. Lidocaine Structure with formal and Mole wt Prilocaine with formula and mole weight
💬 Information for Patients ▾
Information for Patients Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to 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.