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Lidocaine and Prilocaine 25 mg/g; 25 mg/g Cream, 30 g — NDC 68071-1625-3 (Billing 68071-1625-03)

by NuCare Pharamceuticals,Inc. · 30 g in 1 BOX

This is a package of 30 g of Lidocaine and Prilocaine 25 mg/g; 25 mg/g Cream from NuCare Pharamceuticals,Inc., marketed since Sep 2003 and currently FDA-listed. It is this product's only package size.

NDC 68071-1625-03
🏷️ FDA NDC (as labeled) 68071-1625-3 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68071-1625-3
Product NDC 68071-1625
11-digit billing NDC 68071162503
NCPDP billing unit GM — per gram (weight)
RxCUI 197877
UNII 98PI200987, 046O35D44R
UPC 0368071162530
Application # ANDA076290
SPL Set ID 5900691d-8b50-7752-e053-2991aa0a5c5c
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2003-09-25
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE; PRILOCAINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90859902903710
GPI class Lidocaine-Prilocaine
Quick answers
  • GPI-14 (Medi-Span): 90859902903710
  • RxCUI (RxNorm): 197877
Why two NDCs? The FDA registers this code as 68071-1625-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68071-1625-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3852 $11.56 / 30 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68071-1625-03 You're viewing this Main listing 30 g in 1 BOX 2017-09-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine and Prilocaine 25 mg/g; 25 mg/g 00121-1002-30 PAI 1 tube $0.221 — Discontinued —
Lidocaine and Prilocaine 25 mg/g; 25 mg/g 00168-0357-30 E. 1 tube $0.232 AB Availability likely —
Lidocaine And Prilocaine 25 mg/g; 25 mg/g 00574-2042-30 Padagis 1 tube $0.232 AB Availability likely —
Lidocaine And Prilocaine Lidocaine And Prilocaine 25 mg/g; 25 mg/g 21922-0076-05 Encube 1 tube $0.232 AB Availability likely —
Lidocaine and prilocaine 25 mg/g; 25 mg/g 72578-0165-06 Viona 1 tube $0.232 AB Availability likely —
Lidocaine and Prilocaine 25 mg/g; 25 mg/g 62332-0582-04 Alembic 1 tube $1.335 AB Availability likely —
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/gthis 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 —
Lidocaine and prilocaine 25 mg/g; 25 mg/g 50090-8089-00 A-S 1 tube — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2003
On the market since
Sep 2003
📍
2026
Currently FDA-listed
23 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNuCare Pharamceuticals,Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA076290 (ANDA)
Labeler code68071
First marketedSep 2003
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 85 words ▾

INDICATIONS AND USAGE Lidocaine 2.5% and prilocaine 2.5% cream (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 2.5% and prilocaine 2.5% cream 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 ).

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Adult Patients − Intact Skin A thick layer of lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream (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 2.5% and prilocaine 2.5% cream, 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 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream (1 g/10 cm 2 ) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine 2.5% and prilocaine 2.5% cream.

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 (5-10 grams) of lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine 2.5% and prilocaine 2.5% cream.

Pediatric Patients − Intact Skin The following are the maximum recommended doses, application areas and application times for lidocaine 2.5% and prilocaine 2.5% cream based on a child’s age and weight: Age and Body Weight Requirements Maximum Total Dose of lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream (see PRECAUTIONS ). When applying lidocaine 2.5% and prilocaine 2.5% cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine 2.5% and prilocaine 2.5% cream or the occlusive dressing.

A secondary protective covering to prevent inadvertent disruption of the application site may be useful. L idocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agent… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 37 words ▾

CONTRAINDICATIONS lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 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 ~2 min read ▾

WARNINGS Application of lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream has an ototoxic effect when instilled into the middle ear.

In these same studies, animals exposed to lidocaine 2.5% and prilocaine 2.5% cream only in the external auditory canal, showed no abnormality. lidocaine 2.5% and prilocaine 2.5% cream should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible. Methemoglobinemia Lidocaine 2.5% and prilocaine 2.5% cream should not be used in those rare patients with congenital or idiopathic methemoglobinemia and in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents.

Very young patients or patients with glucose-6-phosphate dehydrogenase deficiencies are more susceptible to methemoglobinemia. Patients taking drugs associated with drug-induced methemoglobinemia such as sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, paraaminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, are also at greater risk for developing methemoglobinemia.

There have been reports of significant methemoglobinemia (20-30%) in infants and children following excessive applications of lidocaine 2.5% and prilocaine 2.5% cream. These cases involved the use of large doses, larger than recommended areas of application, or infants under the age of 3 months who did not have fully mature enzyme systems. In addition, a few of these cases involved the concomitant administration of methemoglobin-inducing agents.

Most patients recovered spontaneously after removal of the cream. Treatment with IV methylene blue may be effective if required. Physicians are cautioned to make sure that parents or other caregivers understand the need for careful application of lidocaine 2.5% and prilocaine 2.5% cream, to ensure that the doses and areas of application recommended in Table 2 are not exceeded (especially in children under the age of 3 months) and to limit the period of application to the minimum required to achieve the desired anesthesia.

Neonates and infants up to 3 months of age should be monitored for Met-Hb levels before, during, and after the application of lidocaine 2.5% and prilocaine 2.5% cream, provided the test results can be obtained quickly.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Localized Reactions: During or immediately after treatment with lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream have been reported. The relationship to lidocaine 2.5% and prilocaine 2.5% cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 lidocaine 2.5% and prilocaine 2.5% cream-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 2.5% and prilocaine 2.5% cream. Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of lidocaine 2.5% and prilocaine 2.5% cream.

In patients treated with lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream-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 2.5% and prilocaine 2.5% cream 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.

🔄 Drug Interactions 110 words ▾

Drug Interactions: Lidocaine 2.5% and prilocaine 2.5% cream 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. Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition (see Methemoglobinemia subsection of WARNINGS ). 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 2.5% and prilocaine 2.5% cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

🤰 Pregnancy 146 words ▾

Use in Pregnancy: Teratogenic Effects: Pregnancy Category B. 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 2.5% and prilocaine 2.5% cream 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 173 words ▾

Pediatric Use: Controlled studies of lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream should be used with care in patients with conditions or therapy associated with methemoglobinemia (see Methemoglobinemia subsection of WARNINGS ).

When using lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream for heel lancing in neonates.

🧓 Geriatric Use 181 words ▾

Geriatric Use: Of the total number of patients in clinical studies of lidocaine 2.5% and prilocaine 2.5% cream, 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 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream. 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 133 words ▾

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 µ g/mL for lidocaine and 0.02 to 0.10 µ g/mL for prilocaine. Toxic levels of lidocaine (> 5 µ g/mL) and/or prilocaine (> 6 µ g/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 ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action: Lidocaine 2.5% and prilocaine 2.5% cream, 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 2.5% and prilocaine 2.5% cream depend primarily on the duration of application. To provide sufficient analgesia for clinical procedures such as intravenous catheter placement and venipuncture, lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream 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 variations in the range of 5 to 45 minutes).

Dermal application of lidocaine 2.5% and prilocaine 2.5% cream may cause a transient, local blanching followed by a transient, local redness or erythema. Pharmacokinetics: Lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream (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. Table 1 Absorption of Lidocaine and Prilocaine from Lidocaine 2.5% and Prilocaine 2.5% cream: Normal Volunteers (N=16) Lidocaine 2.5% and Prilocaine 2.5% Cream (g) Area (cm 2 ) Time on (hrs) Drug Content (mg) Absorbed (mg) C max (µg/mL) T max (hr) 60 400 3 lidocaine 1500 54 0.12 4 prilocaine 1500 92 0.07 4 60 400 24 Maximum recommended duration of exposure is 4 hours. lidocaine 1500 243 0.28 10 prilocaine 1500 503 0.14 10 When 60 g of lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream 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 fo… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 60 words ▾

HOW SUPPLIED Lidocaine 2.5% and Prilocaine 2.5% Cream is available as the following: NDC 68071-1625-3 Box of 30g NOT FOR OPHTALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP]. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 667:02 7/09 MG #16518

📋 Description 191 words ▾

DESCRIPTION Lidocaine 2.5% and Prilocaine 2.5%, a topical anesthetic agent, 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 15 gram and 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 2.5% and prilocaine 2.5% cream contains lidocaine 25 mg, prilocaine 25 mg, carboxypolymethylene (as a thickening agent), polyoxyethylene fatty acid esters (as emulsifiers), purified water to 1 gram, and sodium hydroxide to adjust pH (pH range 9.0-9.4).

Lidocaine 2.5% and prilocaine 2.5% cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine 2.5% and prilocaine 2.5% cream is 1.00. Lidocaine Structural Formula Prilocaine Structural Formula

💬 Information for Patients 82 words ▾

Information for Patients: When lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream should not be applied near the eyes or on open wounds.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: Repeated doses of lidocaine 2.5% and prilocaine 2.5% cream may increase blood levels of lidocaine and prilocaine. lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream should not be applied to open wounds. Care should be taken not to allow lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream 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 paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream on intradermal injections of live vaccines has not been determined. Information for Patients: When lidocaine 2.5% and prilocaine 2.5% cream 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 2.5% and prilocaine 2.5% cream should not be applied near the eyes or on open wounds. Drug Interactions: Lidocaine 2.5% and prilocaine 2.5% cream 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.

Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition (see Methemoglobinemia subsection of WARNINGS ). 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 2.5% and prilocaine 2.5% cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

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 2.5% and prilocaine 2.5% cream to 400 cm 2 for 3 hours to a small person (50 kg).

The typical application of lidocaine 2.5% and prilocaine 2.5% cream 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 7,200 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 m… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 44 words ▾

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

🔬 Clinical Studies ~3 min read ▾

Clinical Studies Lidocaine 2.5% and prilocaine 2.5% cream application in adults prior to IV cannulation or venipuncture was studied in 200 patients in four clinical studies in Europe. Application for at least 1 hour provided significantly more dermal analgesia than placebo cream or ethyl chloride. Lidocaine 2.5% and prilocaine 2.5% cream was comparable to subcutaneous lidocaine, but was less efficacious than intradermal lidocaine.

Most patients found lidocaine 2.5% and prilocaine 2.5% cream treatment preferable to lidocaine infiltration or ethyl chloride spray. Lidocaine 2.5% and prilocaine 2.5% cream was compared with 0.5% lidocaine infiltration prior to skin graft harvesting in one open label study in 80 adult patients in England. Application of lidocaine 2.5% and prilocaine 2.5% cream for 2 to 5 hours provided dermal analgesia comparable to lidocaine infiltration.

Lidocaine 2.5% and prilocaine 2.5% cream application in children was studied in seven non-US studies (320 patients) and one US study (100 patients). In controlled studies, application of lidocaine 2.5% and prilocaine 2.5% cream for at least 1 hour with or without presurgical medication prior to needle insertion provided significantly more pain reduction than placebo. In children under the age of seven years, lidocaine 2.5% and prilocaine 2.5% cream was less effective than in older children or adults.

Lidocaine 2.5% and prilocaine 2.5% cream was compared with placebo in the laser treatment of facial port-wine stains in 72 pediatric patients (ages 5−16). Lidocaine 2.5% and prilocaine 2.5% cream was effective in providing pain relief during laser treatment. Lidocaine 2.5% and prilocaine 2.5% cream alone was compared with lidocaine 2.5% and prilocaine 2.5% cream followed by lidocaine infiltration and lidocaine infiltration alone prior to cryotherapy for the removal of male genital warts.

The data from 121 patients demonstrated that lidocaine 2.5% and prilocaine 2.5% cream was not effective as a sole anesthetic agent in managing the pain from the surgical procedure. The administration of lidocaine 2.5% and prilocaine 2.5% cream prior to lidocaine infiltration provided significant relief of discomfort associated with local anesthetic infiltration and thus was effective in the overall reduction of pain from the procedure only when used in conjunction with local anesthetic infiltration of lidocaine. Lidocaine 2.5% and prilocaine 2.5% cream was studied in 105 full term neonates (gestational age: 37 weeks) for blood drawing and circumcision procedures.

When considering the use of lidocaine 2.5% and prilocaine 2.5% cream in neonates, the primary concerns are the systemic absorption of the active ingredients and the subsequent formation of methemoglobin. In clinical studies performed in neonates, the plasma levels of lidocaine, prilocaine, and methemoglobin were not reported in a range expected to cause clinical symptoms. Local dermal effects associated with lidocaine 2.5% and prilocaine 2.5% cream application in these studies on intact skin included paleness, redness and edema and were transient in nature (see ADVERSE REACTIONS ).

The application of lidocaine 2.5% and prilocaine 2.5% cream on genital mucous membranes for minor, superficial surgical procedures (eg, removal of condylomata acuminata) was studied in 80 patients in a placebo-controlled clinical trial (60 patients received lidocaine 2.5% and prilocaine 2.5% cream and 20 patients received placebo). Lidocaine 2.5% and prilocaine 2.5% cream (5 to 10 g) applied between 1 and 75 minutes before surgery, with a median time of 15 minutes, provided effective local anesthesia for minor superficial surgical procedures.

The greatest extent of analgesia, as measured by VAS scores, was attained after 5 to 15 minutes’ application. The application of lidocaine 2.5% and prilocaine 2.5% cream to genital mucous membranes as pretreatment for local anesthetic infiltration was studied in a double-blind, placebo-controlled study in 44 f… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

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 2.5% and prilocaine 2.5% cream to 400 cm 2 for 3 hours to a small person (50 kg).

The typical application of lidocaine 2.5% and prilocaine 2.5% cream 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 7,200 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 test 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 .

📄 Package Label / Principal Display Panel 4 words ▾

PRINCIPAL DISPLAY PANEL PDP

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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