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LIDOCAINE AND PRILOCAINE 25 mg/g; 25 mg/g Cream — NDC 21922-0076-05 package photo

LIDOCAINE AND PRILOCAINE 25 mg/g; 25 mg/g Cream

by Encube Ethicals, Inc. · 1 TUBE in 1 CARTON (21922-076-05) / 30 g in 1 TUBE
NDC 21922-0076-05
🏷️ FDA NDC (as labeled) 21922-076-05 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 21922-076-05
Product NDC 21922-076
11-digit billing NDC 21922007605
NCPDP billing unit GM — per gram (weight)
RxCUI 197877
UNII 98PI200987, 046O35D44R
Application # ANDA076320
SPL Set ID a65a29ca-9476-4290-9384-67df4caec655
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 2024-12-12
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE; PRILOCAINE
GPI-14 90859902903710
GCN Seq No 035495
GCN 05987
HICL code 016196
Ingredient (HICL) Lidocaine/Prilocaine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 72:00.00.00
AHFS class Local Anesthetics
FDB label name LIDOCAINE-PRILOCAINE CREAM
FDB brand name Lidocaine-Prilocaine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 21922-076-05 — a 5-3-2 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 product segment → 21922-0076-05. 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.

🏭 Manufacturer & labeler

LabelerEncube Ethicals, Inc.
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA076320 (ANDA)
Labeler code21922
First marketedDec 2024
Product typeHuman Prescription Drug
Portfolio77 products on file
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.

🩺 Clinical

Label name LIDOCAINE-PRILOCAINE CREAM Ingredient Lidocaine/Prilocaine
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.

🧪 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 02NG325BQG
    A synthetic oil made by chemically treating castor oil. It acts as a solubilizer and emulsifier to help mix water and oily ingredients together in liquid medicines.
  • 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 DailyMedingredient 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.

💲 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 $0.221 $6.63 / 30 g
Medicaid paysCMS SDUD · 12 mo $0.4531 $13.59 / 30 g
Medicare drug plans payPart D · Q2 2026 $0.3852 $11.56 / 30 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.272 $0.216
▼ Down 19% over the last 9 months.
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.

🔁 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 $0.221 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/gthis 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
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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 21922-0076-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
14.2K
Units reimbursed last 4 qtrs
594K
Gross reimbursed last 4 qtrs
$269.1K
Avg / prescription
$19.00
Avg / unit
$0.4531
Latest quarter Q4 2025
10KRx
Medicaid pays / g
$0.4531
gross reimbursed
vs
NADAC / g
$0.2211
acquisition cost
=
Spread
+$0.2320
+105% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
47% FFS 53% MCO
Fee-for-service · 6,717 Rx Managed care · 7,444 Rx
State Medicaid map
Alaska: 960 units · 131 per 100k residents AK Maine: 510 units · 36.6 per 100k residents ME Washington: 12,480 units · 160 per 100k residents WA Idaho: 2,070 units · 105 per 100k residents ID Montana: 450 units · 39.8 per 100k residents MT North Dakota: no data reported ND Minnesota: 8,400 units · 146 per 100k residents MN Wisconsin: 8,700 units · 147 per 100k residents WI Michigan: 28,766 units · 287 per 100k residents MI New York: 50,465 units · 258 per 100k residents NY Vermont: 3,900 units · 603 per 100k residents VT New Hampshire: 660 units · 47.1 per 100k residents NH Oregon: 16,872 units · 399 per 100k residents OR Nevada: 18,960 units · 594 per 100k residents NV Wyoming: no data reported WY South Dakota: 330 units · 35.9 per 100k residents SD Iowa: 1,380 units · 43.0 per 100k residents IA Illinois: 3,690 units · 29.4 per 100k residents IL Indiana: 13,435 units · 196 per 100k residents IN Ohio: 29,534 units · 251 per 100k residents OH Pennsylvania: 5,730 units · 44.2 per 100k residents PA New Jersey: 12,240 units · 132 per 100k residents NJ Massachusetts: 5,970 units · 85.3 per 100k residents MA California: 137,000 units · 352 per 100k residents CA Utah: 3,300 units · 96.6 per 100k residents UT Colorado: 17,760 units · 302 per 100k residents CO Nebraska: 900 units · 45.5 per 100k residents NE Missouri: 5,130 units · 82.8 per 100k residents MO Kentucky: 10,941 units · 242 per 100k residents KY West Virginia: 2,940 units · 166 per 100k residents WV Virginia: 9,560 units · 110 per 100k residents VA Maryland: 10,920 units · 177 per 100k residents MD Connecticut: 4,620 units · 128 per 100k residents CT Rhode Island: 780 units · 71.2 per 100k residents RI Arizona: 9,420 units · 127 per 100k residents AZ New Mexico: 5,670 units · 268 per 100k residents NM Kansas: 600 units · 20.4 per 100k residents KS Arkansas: 1,680 units · 54.8 per 100k residents AR Tennessee: 10,110 units · 142 per 100k residents TN North Carolina: 77,472 units · 715 per 100k residents NC South Carolina: 3,330 units · 62.0 per 100k residents SC Delaware: 1,590 units · 154 per 100k residents DE Oklahoma: 2,987 units · 73.7 per 100k residents OK Louisiana: 10,530 units · 230 per 100k residents LA Mississippi: 1,290 units · 43.9 per 100k residents MS Alabama: 4,950 units · 96.9 per 100k residents AL Georgia: 8,940 units · 81.1 per 100k residents GA D.C.: no data reported DC Hawaii: 2,220 units · 155 per 100k residents HI Texas: 8,940 units · 29.3 per 100k residents TX Florida: 14,940 units · 66.1 per 100k residents FL
Units reimbursed · per 100k residents
20.4715
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 North Carolina 715 /100k
2 Vermont 603 /100k
3 Nevada 594 /100k
4 Oregon 399 /100k
5 California 352 /100k
6 Colorado 302 /100k
7 Michigan 287 /100k
8 New Mexico 268 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
21922-0076-05 You're viewing this 1 TUBE in 1 CARTON (21922-076-05) / 30 g in 1 TUBE 2024-12-12 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 85 words

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 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 and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FORAPPLICATION ). Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine 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 and prilocaine cream, two sites were usually prepared in case there was a technical problem wi1h 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 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 lo local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (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.

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 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 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.

Pediatric Patients-Intact Skin The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight: Age and Body Weight Requirements Maximum Total Dose of Lidocaine and Prilocaine Cream Maximum Application Area Maximum Application Time 0 up t0 3 months or < 5 kg 1g 10 cm 2 1 hour 3 up t012 months and > 5 kg 2g 20 cm 2 4 hours 1 to 6 years and > 10 kg 10g 100 cm2 4 hours 7 to 12 years and > 20 20g 200 cm2 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 should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION ).

Practitioners should carefully ins1rucl caregivers lo avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS). When applying lidocaine and prilocaine cream 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, or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

Lidocaine and prilocaine 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 methemoglobln-lnduclng agents (see Methemoglobinemia subsection of WARNINGS). When lidocaine and prilocaine cream is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all fomulations must be considered (see Individualization of Dose). The amount absorbed in the case of Iidocaine and prilocaine cream is determined by the area over which ii is applied and the durati…

Contraindications 30 words

CONTRAINDICATIONS Lidocaine and prilocaine cream 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 ~1 min read

WARNINGS Application of lidocaine and prilocaine 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 (e.g., amiodarone, bretylium, sotalol, dofetilide} should be under close surveillance and ECG monitoring considered, because cardiac affects may be additive. Studies in laboratory animals (guinea pigs) have shown that lidocaine and prilocaine cream has an ototoxic effect when instilled into the middle ear.

In these same studies, animals exposed to lidocaine and prilocaine cream only in the external auditory canal, showed no abnormality. Lidocaine and prilocaine 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 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 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 ~2 min read

ADVERSE REACTIONS Localized Reactions: During or immediately after treatment with lidocaine and prilocaine 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 and prilocaine cream have been reported.

The relationship to lidocaine and prilocaine cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 lidocaine and prilocaine 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 and prilocaine cream.

Two recent reports describe blistering on the foreskin in neonates abou1 to undergo circumcision. Both neonates received 1.0 g of lidocaine and prilocaine cream. In patients treated with lidocaine and prilocaine 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 and prilocaine 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 and prilocaine 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 cardio vascular collapse leading to arrest.

🔄 Drug Interactions 160 words

Drug Interactions Lidocaine and prilocaine 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. 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/Nitrates 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 be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

🤰 Pregnancy 144 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 lo 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 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 HCI and prilocaine HCI at 1:1 (w/w).

At 40 mg/kg each, a dose equivalent to 29 limes SDA lidocaine and 25 limes SDA prilocaine, no teratogenic, embryotoxic or fetotoxic effects were observed.

🧒 Pediatric Use 165 words

Pediatric Use Controlled studies of lidocaine and prilocaine 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 emo1ional and psychological support of younger children undergoing medical or surgical procedures. Lidocaine and prilocaine cream 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 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 for heel lancing in neonates.

🧓 Geriatric Use 175 words

Geriatric Use Of the total number of patients in clinical studies of lidocaine and prilocaine 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 nongeriatric patients following application of a thick layer of lidocaine and prilocaine 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 and prilocaine 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 126 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 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 overdoi;age from other sources of lidocaine, prilocaine or other local anesthetics. Consult the package inserts for parenteral Xylocaine (lidocaine HCI) or Citanest (prilocaine HCI) forfurther information for the management of overdose.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Mechanism of Action: Lidocaine and prilocaine 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 and prilocaine cream 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 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 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 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 and prilocaine cream may cause a transient, local blanching followed by a transient, local redness or erythema. Pharmacokinetics: Lidocaine and prilocaine 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 and prilocaine 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 and prilocaine 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 and Prilocaine Cream: Normal Volunteers (N=16) Lidocaine and Prilocaine Cream (g) Area (cm 2 ) Time an (hrs) Drug Content (mg) Absorbed (mg) c max (Um/mL) T max (hr ) 60 400 3 lidocaine 1500 54 0.12 4 prilocaine 1500 92 0.07 4 60 400 24* lidocaine 1500 243 0.28 10 prilocaine 1500 503 0.14 10 *Maximum recommended duration of exposure is 4 hours. When 60 g of lidocaine and prilocaine 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 and prilocaine 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 following lidocaine and prilocaine cream application in this study were consistently low (2.5 to 16 ng/ml for lidocaine and 2.5…

📦 How Supplied / Storage and Handling 133 words

HOW SUPPLIED Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following: NDC 21922-076-05: 30 gram tube, box of 1 Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of Encube Ethicals Pvt. Ltd. NOT FOR OPHTHALMIC USE.

KEEP CONTAINERTIGHTLYCLOSEDATALL TIMES WHEN NOT IN USE. Store al 20 0 to 25 0 C (68 0 to 77 0 F); excursions permitted between 15 0 to 30 0 C (59 0 to 86 0 F). [see USP Controlled Room Temperature]. Keep out of the reach of children.

Manufactured by: Encube Ethicals Pvt. Ltd. Plot No.

C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Rev.

06/2023

📋 Description 175 words

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 5 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 and prilocaine cream contains lidocaine 25 mg. prilocaine 25 mg, purified water, PEG-60/hydrogenated castor oil, carbopol 5984 and sodium hydroxide to adjust pH to approximately 9.

Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00. lidocaine-str prilocaine-str

💬 Information for Patients 138 words

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 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 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 shouId 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 should not be applied near the eyes or on open wounds.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.