Lidocaine 20 mg/mL Jelly — NDC 72485-611-30 (Billing 72485-0611-30)
This is a package of Lidocaine 20 mg/mL Jelly from ARMAS PHARMACEUTICALS INC., marketed since Mar 2025 and currently FDA-listed; retail pharmacies pay about $3.23 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 72485-611-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72485 labeler · 611 product · 30 package
- Package marketed since
- Mar 2, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0372485611300, 0372485611317
- Medicaid fills, this package
- 6,430 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Lidocaine Hydrochloride (different manufacturers) — 6 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003407
- GCN: 11870
- GPI-14 (Medi-Span): 90850060104006
- HICL (First Databank): 001478
- AHFS class code: 52:16.00.00
- RxCUI (RxNorm): 1011852
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antiarrhythmic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
- Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
- No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
- Can I use a heating pad with a lidocaine patch?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $3.226 | $96.77 / 30 ml |
| Medicaid paysCMS SDUD · 12 mo | $3.88 | $116.47 / 30 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 72485-0611-10 72485-611-10 | 1 TUBE in 1 CARTON / 5 mL in 1 TUBE | — | — | 2025-03-02 | — | Active |
| 72485-0611-30 You're viewing this Main listing | 1 TUBE, WITH APPLICATOR in 1 CARTON / 30 mL in 1 TUBE, WITH APPLICATOR | $3.23 / mL | $96.77 | 2025-03-02 | — | Active |
| 72485-0611-31 72485-611-31 | 10 TUBE in 1 CARTON / 5 mL in 1 TUBE | — | — | 2025-03-02 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Lidocaine 20 mg/mL Jelly?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lidocaine Hydrochloride 20 mg/mL 76329-3013-05 | International | 25 vials | $0.704 | AT | Availability likely | save 78% |
| glydo 20 mg/mL 25021-0673-76 | Sagent | 10 syringes | $0.898 | AT | Availability likely | save 72% |
| Lidocaine Hydrochloride 20 mg/mL 76329-3011-05 | International | 25 vials | $1.167 | AT | Availability likely | save 64% |
| Lidocaine Hydrochloride 20 mg/mL 76329-3012-05 | International | 25 vials | $1.167 | AT | Availability likely | save 64% |
| Lidocaine 20 mg/mLthis 72485-0611-30 | ARMAS | 1 tube | $3.226 | AT | Availability likely | — |
| Lidocaine Hydrochloride 20 mg/mL 00404-9898-10 | Henry | 1 vial | — | AT | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mL 00404-9899-20 | Henry | 1 vial | — | AT | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mL 00404-9900-05 | Henry | 1 vial | — | AT | FDA listed | — |
| First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel 20 mg/g 00924-5004-00 | Acme | 3.5 g | — | — | FDA listed | — |
| First Aid Only Burn 20 mg/g 00924-5010-00 | Acme | 3.5 g | — | — | FDA listed | — |
| Burn 20 mg/g 43473-0048-01 | Nantong | 9 g | — | — | FDA listed | — |
| PO First Aid Series BURN 2 g/100g 43473-0062-01 | Nantong | 9 g | — | — | FDA listed | — |
| JJ Care BURN 2 g/100g 43473-0069-01 | Nantong | 9 g | — | — | FDA listed | — |
| Lightning X Burn Relief Gel 2 g/100g 43473-0121-01 | Nantong | 9 g | — | — | FDA listed | — |
| Medi-First Burn 20 mg/g 47682-0477-69 | Unifirst | 6 packets | — | — | FDA listed | — |
| Lidocaine Hci 20 mg/mL 51662-1389-01 | HF | 5 ml | — | AT | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mL 51662-1551-03 | HF | 25 pouches | — | AT | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mL 51662-1552-03 | HF | 25 pouches | — | AT | FDA listed | — |
| Burn Ease 2 g/100g 58228-2010-01 | ProStat | 25 packets | — | — | FDA listed | — |
| PROSTAT FIRST AID Burn Ease, 0.9g 2 g/100g 58228-2012-01 | ProStat | 25 packets | — | — | FDA listed | — |
| Burn Ease Cooling 2 g/100g 58228-2893-05 | ProStat | 2000 packets | — | — | FDA listed | — |
| Burn Ease 2 g/100g 58228-3831-02 | ProStat | 20 packets | — | — | FDA listed | — |
| Burn Ease 2 g/100g 58228-3832-02 | ProStat | 6 packets | — | — | FDA listed | — |
| PS-3866 Burn Ease, 0.9g 2 g/100g 58228-3866-01 | ProStat | 10 packets | — | — | FDA listed | — |
| PROSTAT FIRST AID Burn Ease, 0.9g 2 g/100g 58228-3867-01 | ProStat | 10 packets | — | — | FDA listed | — |
| Burn Ease, 3.5g 2 g/100g 58228-3883-01 | ProStat | 2000 packets | — | — | FDA listed | — |
| PS-3885 Burn Ease, 3.5g 2 g/100g 58228-3885-01 | ProStat | 6 packets | — | — | FDA listed | — |
| Burn Ease 2 g/100g 58228-6210-01 | Front | 25 packets | — | — | FDA listed | — |
| FL Burn Ease, 0.9g 2 g/100g 58228-6212-01 | ProStat | 25 packets | — | — | FDA listed | — |
| Burn Ease 3.5g 2 g/100g 58228-6231-01 | Front | 20 packets | — | — | FDA listed | — |
| Burn Ease 3.5g 2 g/100g 58228-6232-01 | Front | 6 packets | — | — | FDA listed | — |
| Burn Ease 3.5g 2 g/100g 58228-6283-01 | Front | 2000 packets | — | — | FDA listed | — |
| Lidoease 2% 20 mg/g 59088-0221-03 | PureTek | 28.35 g | — | — | FDA listed | — |
| Burn Jel 2 g/100mL 59898-0200-11 | Water-Jel | 24 bottles | — | — | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/g 61010-5000-00 | Safetec | 3.3 g | — | — | FDA listed | — |
| Aloe Ice Sunburn Relief 2 g/100mL 61477-0101-11 | Aloe | 60 ml | — | — | FDA listed | — |
| Regenecare Ha 20 mg/g 66977-0107-03 | MPM | 85 g | — | — | FDA listed | — |
| XeroBurn Burn Gel 2 g/100g 67777-0129-02 | Dynarex | 1728 packets | — | — | FDA listed | — |
| Burn Gel .02 g/g 69396-0106-09 | Trifecta | 144 packets | — | — | FDA listed | — |
| Redicare Burn Gel 20 mg/g 71105-0500-02 | Redicare | 15 packets | — | — | FDA listed | — |
| Jelcaine Sterile 20 mg/mL 71351-0025-30 | Brookfield | 30 ml | — | — | FDA listed | — |
| Lidocaine Hydrochloride 20 mg/mL 76329-3015-05 | International | 25 vials | — | AT | FDA listed | — |
| Burn 20 mg/g 82942-1001-01 | J&A | 9 g | — | — | FDA listed | — |
| Lidomax 20 mg/g 85477-0304-07 | Oncora | 85 g | — | — | FDA listed | — |
| Collavera 20 mg/g 85477-0305-07 | Oncora | 28.33 g | — | — | FDA listed | — |
| Lidocaine Hydrochloride 2% 2 g/100g 87236-0015-35 | Aldermed | 25 packets | — | — | FDA listed | — |
| Lidocaine 20 mg/mL 70244-0039-01 | Sentiss | 1 tube | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Lidocaine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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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.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from ARMAS PHARMACEUTICALS INC. labeler code 72485
- Haloperidol Decanoate 100 mg/mL Injection NDC 72485-521-10
- Haloperidol Decanoate 500 mg/5mL Injection NDC 72485-522-01
- Desmopressin Acetate 4 ug/mL Injection, Solution NDC 72485-523-10
- Desmopressin Acetate 40 ug/10mL Injection, Solution NDC 72485-524-01
- Carboprost Tromethamine 250 ug/mL Injection, Solution NDC 72485-525-10
- Timolol maleate 6.8 mg/mL Solution NDC 72485-602-60
- Ofloxacin 3 mg/mL Solution/ Drops NDC 72485-613-10
- Ketotifen Fumarate Ophthalmic Solution .25 mg/mL Solution/ Drops NDC 72485-617-10
- Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL Suspension/ Drops NDC 72485-625-13
- Loteprednol Etabonate 5 mg/g Gel NDC 72485-630-05
- Brimonidine Tartrate/Timolol Maleate 2 mg/mL; 5 mg/mL Solution/ Drops NDC 72485-634-05
- Bromfenac 1.035 mg/mL Solution/ Drops NDC 72485-649-71
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Lidocaine HCl 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION When Lidocaine HCl 2% Jelly is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered.
Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with Lidocaine HCl 2% Jelly is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. For Surface Anesthesia of the Male Adult Urethra: When using Lidocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube.
The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill approximately 15 mL (300 mg of lidocaine HCl) into the urethra or until the patient has a feeling of tension. A penile clamp is then applied for several minutes at the corona.
An additional dose of not more than 15 mL (300mg) can be instilled for adequate anesthesia. Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. A total dose of 30 mL (600 mg) is usually required to fill and dilate the male urethra.
Prior to catheterization, smaller volumes of 5 to 10 mL (100 to 200 mg) are usually adequate for lubrication. For Surface Anesthesia of the Female Adult Urethra: When using Lidocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred.
Slowly instill 3 to 5 mL (60 to 100 mg of lidocaine HCl) of the jelly into the urethra. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra. In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.
Lubrication for Endotracheal Intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before use. Care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate endotracheal stylettes (see WARNINGS and ADVERSE REACTIONS ) concerning rare reports of inner lumen occlusion.
It is also recommended that use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.
⛔ Contraindications ▾
CONTRAINDICATIONS Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine HCl 2% Jelly.
⚠️ Warnings ▾
WARNINGS EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS.
Lidocaine HCl 2% Jelly should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption. When used for endotracheal tube lubrication care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate the endotracheal stylettes.
If allowed into the inner lumen, the jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen. There have been rare reports in which this residue has caused the lumen to occlude (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION ). 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 HCl 2% Jelly 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 Adverse experiences following the administration of lidocaine are similar in nature to those observed in other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy, or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.
The following types are those most commonly reported: There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube (see WARNINGS and DOSAGE AND ADMINISTRATION ). Central Nervous System: CNS manifestations are excitatory and/or depressant and may be characterized by 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.
The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular System: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse which may lead to cardiac arrest.
Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema, or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or other components in the formulation. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means.
The detection of sensitivity by skin testing is of doubtful value. To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions 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 Antineoplastics 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 Carcinogenesis - Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lidocaine.
Mutagenesis - The mutagenic potential of lidocaine has been tested in the Ames Salmonella reverse mutation assay, and an in vitro chromosome aberrations assay in human lymphocytes and in an in vivo mouse micronucleus assay. There was no indication of any mutagenic effect in these studies. Impairment of Fertility - The effect of lidocaine on fertility was examined in the rat model.
Administration of 30 mg/kg, s.c. (180 mg/m 2 ) to the mating pair did not produce alterations in fertility or general reproductive performance of rats. There are no studies that examine the effect of lidocaine on sperm parameters.
There was no evidence of altered fertility.
🤰 Pregnancy ▾
Use in Pregnancy: Teratogenic Effects Reproduction studies for lidocaine have been performed in both rats and rabbits. There was no evidence of harm to the fetus at subcutaneous doses of up to 50 mg/kg lidocaine (300 mg/m 2 on a body surface area basis) in the rat model. In the rabbit model, there was no evidence of harm to the fetus at a dose of 5 mg/kg, s.c.
(60 mg/m 2 on a body surface area basis). Treatment of rabbits with 25 mg/kg (300 mg/m 2 ) produced evidence of maternal toxicity and evidence of delayed fetal development, including a non-significant decrease in fetal weight (7%) and an increase in minor skeletal anomalies (skull and sternebral defect, reduced ossification of the phalanges). The effect of lidocaine on post-natal development was examined in rats by treating pregnant female rats daily subcutaneously at doses of 2, 10, and 50 mg/kg (12, 60, and 300 mg/m 2 ) from day 15 of pregnancy and up to 20 days post partum.
No signs of adverse effects were seen either in dams or in the pups up to and including the dose of 10 mg/kg (60 mg/m 2 ); however, the number of surviving pups was reduced at 50 mg/kg (300 mg/m 2 ), both at birth and the duration of lactation period, the effect most likely being secondary to maternal toxicity. No other effects on litter size, litter weight, abnormalities in the pups and physical developments of the pups were seen in this study. A second study examined the effects of lidocaine on post-natal development in the rat that included assessment of the pups from weaning to sexual maturity.
Rats were treated for 8 months with 10 or 30 mg/kg, s.c. lidocaine (60 mg/m 2 and 180 mg/m 2 on a body surface area basis, respectively). This time period encompassed 3 mating periods. There was no evidence of altered post-natal development in any offspring; however, both doses of lidocaine significantly reduced the average number of pups per litter surviving until weaning of offspring from the first 2 mating period.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use: Although the safety and effectiveness of Lidocaine 2% Jelly in pediatric patients have not been established, a study of 19 premature neonates (gestational age <33 weeks) found no correlation between the plasma concentration of lidocaine or monoethylglycinexylidide and infant body weight when moderate amounts of lidocaine (i.e. 0.3 mL/kg of lidocaine gel 20 mg/mL) were used for lubricating both intranasal and endotracheal tubes. No neonate had plasma levels of lidocaine above 750 mcg/L.
Dosages in children should be reduced, commensurate with age, body weight, and physical condition (see DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics (see ADVERSE REACTIONS , WARNINGS , and PRECAUTIONS ). Management of Local Anesthetic Emergencies: The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic administration. At the first sign of change, oxygen should be administered.
The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously.
The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine). If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias, and cardiac arrest.
If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Dialysis is of negligible value in the treatment of acute overdosage with lidocaine. The oral LD 50 of lidocaine HCl in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 324) mg/kg (as the salt) in fasted female rats.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Onset of Action: The onset of action is 3 to 5 minutes. It is ineffective when applied to intact skin.
Hemodynamics: Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system. Pharmacokinetics and Metabolism: Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon concentration and total dose administered, the specific site of application, and duration of exposure.
In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug may appear in the circulation because of biotransformation in the liver. Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys.
Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine.
Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration.
At concentrations of 1 to 4 mcg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion.
Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2.0 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged twofold or more in patients with liver dysfunction.
Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 mcg free base per mL.
In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.
🧬 Mechanism of Action ▾
Mechanism of Action: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Onset of Action: The onset of action is 3 to 5 minutes. It is ineffective when applied to intact skin.
Hemodynamics: Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Lidocaine HCl 2% Jelly is supplied in the listed dosage forms. NDC 72485-611-30 30 mL aluminum tube single pack NDC 72485-611-10 5 mL aluminum tube single pack NDC 72485-611-31 5 mL aluminum tube ten pack A detachable applicator cone and a key for expressing the contents are included in the 30 mL carton. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 USA Manufactured by: Ophtapharm AG Riethofstrasse 1, Hettlingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland 83027101 Rev. 04/24
📦 Storage and Handling ▾
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 USA Manufactured by: Ophtapharm AG Riethofstrasse 1, Hettlingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland 83027101 Rev. 04/24
📋 Description ▾
DESCRIPTION Lidocaine HCl 2% Jelly is a sterile aqueous product that contains a local anesthetic agent and is administered topically (see INDICATIONS AND USAGE for specific uses). Lidocaine HCl 2% Jelly contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula: Its molecular formula is C 14 H 22 N 2 O • HCl and its molecular weight is 270.80. Lidocaine HCl 2% Jelly also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation.
The unused portion should be discarded after initial use. Composition of Lidocaine HCl 2% Jelly 30 mL and 5 mL tubes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains methylparaben, propylparaben, hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0 to 7.0.
Structural Formula
💬 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 topical anesthetics are used in the mouth, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration.
For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma.
Food or chewing gum should not be taken while the mouth or throat area is anesthetized.
⚠️ Precautions ▾
PRECAUTIONS General: The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies (see WARNINGS and ADVERSE REACTIONS ). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites.
Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status. Lidocaine should also be used with caution in patients with severe shock or heart block.
Lidocaine HCl 2% Jelly should be used with caution in patients with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia.
Since it is not known whether amide-type local anesthetics may trigger this reaction and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for management should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure, and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before using).
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 topical anesthetics are used in the mouth, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration.
For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma.
Food or chewing gum should not be taken while the mouth or throat area is anesthetized. Drug Interactions 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 Antineoplastics 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 Carcinogenesis - Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lidocaine.
Mutagenesis - The mutagenic potential of lidocaine has been tested in the Ames Salmonella reverse mutation assay, and an in vitro chromosome aberrations assay in human lymphocytes and in an in vivo mouse micronucleus assay. There was no indicat… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers: Lidocaine is secreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when lidocaine is administered to a nursing woman.
🧬 Pharmacokinetics ▾
Pharmacokinetics and Metabolism: Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon concentration and total dose administered, the specific site of application, and duration of exposure. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug may appear in the circulation because of biotransformation in the liver.
Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide.
The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline.
The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein.
Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2.0 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics.
The half-life may be prolonged twofold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects.
Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 mcg free base per mL. In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Text for Container Label: NDC 72485-611-10 Lidocaine Hydrochloride Jelly USP, 2% Rx only Sterile 5 mL 5 ml container
Principal Display Panel Text for Container Label: NDC 72485-611-30 Lidocaine Hydrochloride Jelly USP, 2% Rx only Sterile 30 mL 30 mL tube
Principal Display Panel Text for Carton Label: NDC 72485-611-10 Sterile 5 mL Lidocaine Hydrochloride Jelly USP, 2% Rx only 5 ml carton
Principal Display Panel Text for Carton Label: NDC 72485-611-30 Sterile 30 mL Lidocaine Hydrochloride Jelly USP, 2% Rx only 30 ml carton 1