Lidothol

Lidocaine Hcl, Menthol

Asclemed Usa, Inc.
Human Prescription Drug
NDC 76420-253

Lidothol also known as Lidocaine Hcl, Menthol is a human prescription drug labeled by 'Asclemed Usa, Inc.'. National Drug Code (NDC) number for Lidothol is 76420-253. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Lidothol drug includes Lidocaine Hydrochloride - 4.5 g/100g Menthol - 5 g/100g . The currest status of Lidothol drug is Active.

Drug Information:

Drug NDC:	76420-253
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Lidothol
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Lidocaine Hcl, Menthol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Asclemed Usa, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	LIDOCAINE HYDROCHLORIDE - 4.5 g/100g MENTHOL - 5 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	01 Apr, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	02 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Asclemed USA, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
UNII:	V13007Z41A L7T10EIP3A
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Amide Local Anesthetic [EPC] Amides [CS] Antiarrhythmic [EPC] Local Anesthesia [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
76420-253-04	1 TUBE in 1 BOX (76420-253-04) / 99.2 g in 1 TUBE	19 Jul, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Lidothol

Lidocaine Hcl, Menthol

Gel
Preferred Pharmaceuticals Inc.
NDC: 68788-8129

Lidothol

Lidocaine Hcl, Menthol

Gel
Terrain Pharmaceuticals
NDC: 53225-1026

Lidothol

Lidocaine Hcl, Menthol

Gel
Asclemed USA, Inc.
NDC: 76420-253

Product Elements:

Lidothol lidocaine hcl, menthol magnesium sulfate, unspecified form ilex paraguariensis leaf arnica montana flower phenoxyethanol carboxypolymethylene boswellia serrata resin oil polysorbate 20 butylene glycol water alcohol ethylhexylglycerin dimethyl sulfone trolamine menthol menthol lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous

Indications and Usage:

Indication and usage lidothol gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. it should be applied only to intact skin.

Warnings:

Warnings medicines intended to be applied to the skin should not be swallowed. lidothol gel is flammable. keep away from open flame. you should never heat, microwave, or add the medicine to hot water. risk of methemoglobinemia cases of methemoglobinemia have been reported in association with lidocaine 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 the condition. if lidocaine 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 ris Read more...

e; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. excessive dosing excessive dosing by applying lidothol gel to larger areas could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see adverse reactions, systemic reactions). lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/ml. the blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. longer duration of application of more than the recommended number of doses, smaller patients, or impaired elimination may all contribute to increased blood concentration of lidocaine.

Dosage and Administration:

Contraindications lidothol gel 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.

Dosage and administration apply lidothol gel to intact skin to cover the most painful area. clean and dry the affected area. apply product directly to your skin, up to 4 times daily. clothing may be worn over the area of application. if irritation or a burning sensation occurs during application, wash the product off your skin and do not reapply until the irritation subsides. when lidothol gel is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Adverse Reactions:

Adverse reactions application site reactions during or immediately after treatment with lidothol gel, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. these reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. other adverse events due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including: asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. systemic (dose-related) reactions systemic adverse reacti Read more...

ons following appropriate use of lidothol gel are unlikely, due to the small dose absorbed (see clinical pharmacology, pharmacokinetics). systemic adverse effects of lidocaine is 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. sensitivity reactions associated with the use of mentholated products have been reported. use of mentholated nasal drops in infants has evidently caused isolated cases of spasm of the larynx, and a few cases of nervous or digestive system disturbance have been associated with excessive inhalation or oral exposure to menthol

Overdosage:

Overdosage lidocaine overdose from cutaneous absorption is rare but could occur. if there is any suspicion of lidocaine overdose (see adverse reactions, systemic reactions), drug blood concentration should be checked. the management of overdose includes close monitoring, supportive care, and symptomatic treatment. dialysis is of negligible value in the treatment of acute overdose with lidocaine. in the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics.

Description:

Description lidothol gel (lidocaine 4.5%, menthol 5%) is comprised of a gel inside of a tube containing 4.5% lidocaine and 5% menthol. inactive ingredients: acrylates/c10-30 alkyl acrylate crosspolymer, arnica montana flower extract, boswellia serrata gum extract, butylene glycol, dimethyl sulfone, ethylhexylglycerin, llex paraguariensis leaf extract, magnesium sulfate, phenoxyethanol, polysorbate-20, propylene glycol, sd alcohol 40-b, triethanolamine, water

Clinical Pharmacology:

Clinical pharmacology pharmacodynamics lidocaine is an amide-type local anesthetic agent. the penetration of lidocaine into intact skin after application of lidothol gel is sufficient to produce annalgesic effect, but less than the amount necessary to produce a complete sensory block. menthol is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. menthol induces a cooling sensation on the skin upon topical application by stimulating the cold-sensitive receptors expressed on the skin, without actually causing a drop in the skin temperature. pharmacokinetics absorption the amount of lidocaine systemically absorbed from lidothol gel is directly related to both the duration of application and the surface area over which it is applied. menthol occurs in numerous over-the-counter products. although extensively used, there have been no estimates of human exposure following administration via dermal application. distribution at concentrations produced Read more...

by application of lidothol gel, approximately 70% of the lidocaine dose is reported to be bound to plasma proteins, primarily alpha-1-acid glycoprotein. at higher plasma concentrations (1 to 4 mcg/ml of free base), the plasma protein binding of lidocaine is concentration dependent. metabolism it is not known if lidothol gel is metabolized in the skin. excretion lidocaine and its metabolites are excreted by the kidneys. less than 10% of lidocaine is excreted unchanged. the half-life of lidocaine elimination from the plasma following iv administration is 81 to 149 minutes (mean 107 Â± 22 sd, n = 15). the systemic clearance is 0.33 to 0.90 l/min (mean 0.64 Â± 2 max max 0.18 sd, n = 15).

How Supplied:

How supplied lidothol gel is available as the following: 1 tube, 3.5oz ndc 76420-253-04 (relabeled from ndc 53225-1026-1) store at 25Â°c (77Â°f); excursions permitted to 15Â°-30Â°c (59Â°-86Â°f). [see usp controlled room temperature]. for more information, contact terrain pharmaceuticals. info@terrainrx.com relabeled by: enovachem pharmaceuticals torrance, ca 90501

Package Label Principal Display Panel:

Lidotholbox lidotholinsertp1 lidotholinsertp2

Comments/ Reviews:

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