Lidocaine Hcl

Puretek Corporation
Human Prescription Drug
NDC 59088-997

Lidocaine Hcl is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Lidocaine Hcl is 59088-997. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Lidocaine Hcl drug includes Lidocaine Hydrochloride - 30 mg/g . The currest status of Lidocaine Hcl drug is Active.

Drug Information:

Drug NDC:	59088-997
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:	Lidocaine Hcl
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
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Puretek Corporation
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
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 - 30 mg/g
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:	13 Jun, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 2025
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:	PureTek Corporation
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1010835
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0731477321779
UPC stands for Universal Product Code.
UNII:	V13007Z41A
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
59088-997-03	1 TUBE in 1 CARTON (59088-997-03) / 28.3 g in 1 TUBE	13 Jun, 2011	N/A	No
59088-997-07	1 TUBE in 1 CARTON (59088-997-07) / 85 g in 1 TUBE	13 Jun, 2011	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.

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Product Elements:

Lidocaine hcl lidocaine hcl lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous aluminum sulfate calcium acetate cetyl alcohol methylparaben mineral oil petrolatum polysorbate 60 propanediol propylparaben water sodium hydroxide sorbitan monostearate stearic acid stearyl alcohol

Indications and Usage:

Indications indications : for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.

Warnings:

Warnings for external use only. not for ophthalmic use. keep out of reach of children.

Dosage and Administration:

Dosage and administration: apply a thin film to the affected area two or three times daily or as directed by a physician.

Contraindications:

Contraindications tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Adverse Reactions:

Adverse reactions: during or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

Use in Pregnancy:

Use in pregnancy teratogenic effects: teratogenic effects; pregnancy category b. reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. there are, however, no adequate and well-controlled studies in pregnant women. animal reproduction studies are not always predictive of human response. general consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

Pediatric Use:

Pediatric use: dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.

Description:

Description contains lidocaine hcl 3% in a mild acidic vehicle. lidocaine is chemically designated as acetamide, 2-(diethylamino)-n-(2,6-dimethylphenyl). ingredients: each gram of pharmapure rx lidocaine hcl 3% cream contains lidocaine hcl usp 3%, inactive ingredients include: aluminum sulfate, calcium acetate, cetyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan stearate, stearic acid, stearyl alcohol. image description

Clinical Pharmacology:

Clinical pharmacology enter section text here mechanism of action pharmapure rx lidocaine hcl 3% cream releases lidocaine from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. a mild acidic vehicle lowers ph to increase protection against alkaline irritations and to provide a favorable environment for healing. pharmacokinetics lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration, and total dosage. 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 appears in the circulation because of biotransformation of the liver. lidocaine is Read more...

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 conjungation. n-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexlidide. 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 concentration of 1 to 4 g 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 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 two-fold 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 g free base per ml. in the rhesus monkey arterial blood levels of 18-21 g/ml have been shown to be threshold for convulsive activity. indications indications : for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.

Mechanism of Action:

Mechanism of action pharmapure rx lidocaine hcl 3% cream releases lidocaine from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. a mild acidic vehicle lowers ph to increase protection against alkaline irritations and to provide a favorable environment for healing.

Pharmacokinetics:

Pharmacokinetics lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration, and total dosage. 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 appears in the circulation because of biotransformation of 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 conjungation. n-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexlidide. the pharmacological/toxicological actions of these metabolites are similar to, but less potent than, tho Read more...

se 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 concentration of 1 to 4 g 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 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 two-fold 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 g free base per ml. in the rhesus monkey arterial blood levels of 18-21 g/ml have been shown to be threshold for convulsive activity.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, and impairment of fertility studies of lidocaine in animals to evaluate the carcinogenic potential of the effect on fertility have not been conducted.

How Supplied:

How supplied: pharmapure rx lidocaine hcl 3% cream 1 oz (28.3g) tube - ndc 59088-997-03 3 oz (85 g) tube - ndc 59088-997-07

Package Label Principal Display Panel:

1 oz carton label image description

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.