Neurozyl Cream

Neurozyl Cream
SPL v1
SPL
SPL Set ID 1aca46c8-ff06-da0e-e063-6394a90a475f
Route
TOPICAL
Published
Effective Date 2024-06-13
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Scutellaria Baicalensis Root Salix Alba Bark Oat Passiflora Incarnata Fruit Sodium Phosphate Ethylhexylglycerin Petrolatum Propylene Glycol Calcium Acetate Polyoxyl 20 Cetostearyl Ether Arnica Montana Flower Prezatide Copper Acetate Cetostearyl Alcohol Phenoxyethanol Glycerin Turmeric Water Aloe Vera Leaf Mineral Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-06-13

Description

Lidocaine HCl 4.12% with Arnica & Peptides Topical Anesthetic • Reduces Nerve Pain • Helps Reduce Inflammation Rx Only

Dosage and Administration

Apply a thin film to the affected area two or three times daily or as directed by a licensed healthcare practitioner.

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

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.

How Supplied

Neurozyl™ Cream is supplied in a 3 oz. (85 g) tube with CRC cap (NDC 59088-321-07).


Medication Information

Dosage and Administration

Apply a thin film to the affected area two or three times daily or as directed by a licensed healthcare practitioner.

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

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.

How Supplied

Neurozyl™ Cream is supplied in a 3 oz. (85 g) tube with CRC cap (NDC 59088-321-07).

Description

Lidocaine HCl 4.12% with Arnica & Peptides Topical Anesthetic • Reduces Nerve Pain • Helps Reduce Inflammation Rx Only

Warnings:

For external use only. Not for ophthalmic use.

Description:

Neurozyl™ Cream contains 41.2 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Bis (tripeptide-1) Copper Acetate, Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Curcuma Longa (Turmeric) Root Extract, Ethylhexylglycerin, Glycerin, Mineral Oil, Oat Straw (Avena Sativa) Powder, Passiflora Incarnata Fruit Extract, Petrolatum, Phenoxyethanol, Propylene Glycol, Salix Alba (Willow) Bark Extract, Scutellaria Baicalensis (Chinese Skullcap) Root Extract, Sodium Phosphate.



Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:

Indications:

Neurozyl™ Cream is indicated for the temporary relief of pain.

Precautions:

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Neurozyl™ Cream should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine

How Supplied:

Neurozyl™ Cream is supplied in a 3 oz. (85 g) tube with CRC cap (NDC 59088-321-07).

Pediatric Use:

Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

Neurozyl™ Cream

Lidocaine HCl 4.12% with Arnica & Peptides

Topical Anesthetic • Reduces Nerve Pain • Helps Reduce Inflammation

Rx Only

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 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 of drug concentration, and the fraction bound decreases with increasing concentration. At concentrations 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 the threshold for convulsive activity.



Use in Pregnancy:

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.

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.

Mechanism of Action:

Neurozyl™ 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 irritants and to provide a favorable environment for healing.

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.

Clinical Pharmacology:



Dosage and Administration:

Apply a thin film to the affected area two or three times daily or as directed by a licensed healthcare practitioner.

Keep This and All Medications Out of Reach of Children.

Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Protect from freezing.

Carcinogenesis, Mutagenesis and Impairment of Fertility:

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.


Structured Label Content

Warnings: (WARNINGS:)

For external use only. Not for ophthalmic use.

Description: (DESCRIPTION:)

Neurozyl™ Cream contains 41.2 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Bis (tripeptide-1) Copper Acetate, Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Curcuma Longa (Turmeric) Root Extract, Ethylhexylglycerin, Glycerin, Mineral Oil, Oat Straw (Avena Sativa) Powder, Passiflora Incarnata Fruit Extract, Petrolatum, Phenoxyethanol, Propylene Glycol, Salix Alba (Willow) Bark Extract, Scutellaria Baicalensis (Chinese Skullcap) Root Extract, Sodium Phosphate.



Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:

Indications: (INDICATIONS:)

Neurozyl™ Cream is indicated for the temporary relief of pain.

Precautions: (PRECAUTIONS:)

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Neurozyl™ Cream should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine

How Supplied: (HOW SUPPLIED:)

Neurozyl™ Cream is supplied in a 3 oz. (85 g) tube with CRC cap (NDC 59088-321-07).

Pediatric Use: (PEDIATRIC USE:)

Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.

Nursing Mothers: (NURSING MOTHERS:)

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

Neurozyl™ Cream

Lidocaine HCl 4.12% with Arnica & Peptides

Topical Anesthetic • Reduces Nerve Pain • Helps Reduce Inflammation

Rx Only

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 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 of drug concentration, and the fraction bound decreases with increasing concentration. At concentrations 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 the threshold for convulsive activity.



Use in Pregnancy:

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.

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.

Mechanism of Action:

Neurozyl™ 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 irritants and to provide a favorable environment for healing.

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.

Clinical Pharmacology: (CLINICAL PHARMACOLOGY:)



Dosage and Administration: (DOSAGE AND ADMINISTRATION:)

Apply a thin film to the affected area two or three times daily or as directed by a licensed healthcare practitioner.

Keep This and All Medications Out of Reach of Children. (KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.)

Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Protect from freezing.

Carcinogenesis, Mutagenesis and Impairment of Fertility:

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.


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