Uber Numb Topical Anesthetic

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

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

Limitations of Use: This medication is intended for short-term use and should not be used as a substitute for comprehensive treatment of underlying anorectal conditions.

Dosage and Administration

The affected area should be cleaned with warm water and mild soap, followed by thorough rinsing. After cleansing, the area must be gently dried by patting with toilet tissue or a soft cloth. For adults and children aged 12 years and older, the product should be applied externally to the affected area up to six times per day.

It is advised that a physician be consulted prior to use for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Exceeding the recommended daily dosage is contraindicated unless directed by a healthcare professional, as it may lead to adverse effects. Additionally, insertion of this product into the rectum using fingers or any mechanical device is contraindicated due to the risk of injury or complications.

Warnings and Precautions

For external use only; this product should be utilized strictly as directed.

It is imperative that the recommended daily dosage is not exceeded unless specifically instructed by a healthcare professional. The product must not be inserted into the rectum using fingers or any mechanical device, as this may lead to adverse effects. Additionally, it is advised that children under the age of 12 consult a physician prior to use to ensure safety and appropriateness.

Healthcare professionals should instruct patients to discontinue use of this product if any of the following occur: symptoms worsen or do not improve within seven days, or if bleeding, redness, irritation, swelling, pain, or any other concerning symptoms develop. Monitoring for these adverse reactions is essential to ensure patient safety and effective treatment outcomes.

Side Effects

Patients using this product should be aware that it is intended for external use only and must be used strictly as directed. It is crucial not to exceed the recommended daily dosage unless specifically instructed by a healthcare professional. Additionally, patients should refrain from inserting this product into the rectum using fingers or any mechanical device.

In clinical practice, it is advised to keep this product out of reach of children. For children under the age of 12, consultation with a physician is recommended prior to use.

Patients are instructed to discontinue use and seek medical advice if symptoms worsen or do not improve within seven days. Furthermore, immediate cessation of the product is necessary if any bleeding occurs, or if symptoms such as redness, irritation, swelling, pain, or other adverse reactions develop.

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 Uber 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 physician prior to use. For adolescents aged 12 years and older, it is also recommended to consult a physician before use.

When applying the product, the affected area should be cleaned with warm water and mild soap, followed by thorough rinsing. The area should then be gently dried by patting with toilet tissue or a soft cloth. The product may be applied externally to the affected area up to six times per day.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Safety during pregnancy has not been established for this product. Use is not recommended during pregnancy due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for healthcare providers to consult with a physician before use. Pregnant women should seek medical advice for appropriate dosage and use, as dosage modifications may be necessary. Caution is advised when using this product in pregnant individuals.

Lactation

There are no specific warnings or recommendations regarding the use of Uber Numb Topical Anesthetic in lactating mothers. Additionally, there is no information available about the potential for excretion of the drug in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

Overdosage of the medication can lead to serious health consequences. It is imperative that healthcare professionals adhere to the recommended daily dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, immediate medical attention should be sought. Symptoms of overdosage may vary depending on the specific medication and the extent of the overdose. Healthcare providers should be vigilant for signs and symptoms that may indicate an adverse reaction.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare professionals are advised to monitor the patient closely and provide appropriate interventions based on the clinical presentation.

It is crucial to emphasize that patients should not exceed the recommended daily dosage unless explicitly directed by a qualified healthcare provider. This precaution is essential to prevent potential complications associated with overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients that children under the age of 12 should consult a physician prior to using this product. It is important for patients to be aware that they should discontinue use if their symptoms worsen or do not improve within seven days. Additionally, patients should be instructed to stop using the product if any bleeding occurs or if they experience redness, irritation, swelling, pain, or other concerning symptoms.

Providers should emphasize the importance of adhering to the recommended daily dosage and advise patients not to exceed this dosage unless directed by a healthcare professional. Furthermore, patients must be cautioned against inserting the product into the rectum using fingers or any mechanical device, as this could lead to complications.

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 effectiveness. Proper handling should be observed to prevent exposure to conditions that may compromise the quality of the product.

Additional Clinical Information

Patients should apply the product externally to the affected area up to six times per day. Clinicians are advised to counsel patients, particularly emphasizing that children under 12 years of age should consult a physician prior to use. Patients should discontinue use if symptoms worsen or do not improve within seven days, or if any bleeding, redness, irritation, swelling, pain, or other concerning symptoms develop.

Drug Information (PDF)

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

View product document (PDF)