Advanced Numb Topical Anesthetic

Description

The product is identified by the SPL code 34089-3 and is packaged in a jar.

Uses and Indications

This drug is indicated for the temporary relief of pain and discomfort associated with anorectal disorders.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, it is recommended to cleanse the affected area with mild soap and warm water, followed by thorough rinsing. The area should be gently dried by patting or blotting with toilet tissue or a clean, soft cloth prior to the application of the product. The product may be applied externally up to six times per day for optimum results.

For children under 12 years of age, consultation with a healthcare professional is advised before use.

Contraindications

Use of this product is contraindicated in the following situations:

• Exceeding the recommended daily dosage unless directed by a healthcare professional may lead to adverse effects.

• In the event of bleeding, immediate consultation with a healthcare provider is necessary.

• The product should not be administered rectally using fingers, mechanical devices, or applicators due to the risk of injury or complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor if the condition worsens or does not improve within 7 days of use. It is imperative that patients do not exceed the recommended daily dosage unless specifically directed by a healthcare provider.

In the event of bleeding, patients must be instructed to seek medical attention promptly. Additionally, it is crucial to inform patients that this product should not be inserted into the rectum using fingers, mechanical devices, or applicators, as this may lead to complications.

To ensure safety, this product should be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that the product is for external use only. In the event that the condition worsens or does not improve within 7 days, it is advised to consult a doctor.

It is crucial not to exceed the recommended daily dosage unless directed by a healthcare professional. Should any bleeding occur, patients must seek medical attention promptly. Additionally, the product should not be inserted into the rectum using fingers, mechanical devices, or applicators.

To ensure safety, the product must be kept out of reach of children. If swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Advanced Numb Topical Anesthetic (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents aged 12 years and older, the recommended application is external use up to six times per day. Care should be taken to adhere to these guidelines to ensure safety and efficacy in this age group.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of lidocaine hydrochloride cream during pregnancy has not been established. The use of this product is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay, or the Poison Control Center should be reached for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers are advised to monitor the patient closely for any symptoms that may arise and to initiate appropriate management procedures based on the clinical presentation.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact the Poison Control Center if the product is swallowed. It is important to emphasize that patients should not exceed the recommended daily dosage unless specifically directed by a healthcare professional.

In the event of any bleeding, patients should be instructed to consult a doctor promptly to address potential complications. Additionally, healthcare providers should caution patients against inserting the product into the rectum using fingers, mechanical devices, or applicators, as this could lead to adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from direct sunlight to maintain its integrity and efficacy. Proper handling should be observed to prevent exposure to conditions that may compromise the product's quality.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of up to six times per day. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Advanced Numb Topical Anesthetic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)