Olelon Numbing

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the cleansing of affected areas. It is recommended that the area be cleaned with mild soap and warm water, followed by thorough rinsing. After cleansing, the area should be gently dried by patting with toilet tissue or a soft cloth prior to the application of this product.

For pediatric patients, specifically those under 12 years of age, consultation with a healthcare professional is advised before use.

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

Dosage and Administration

Healthcare professionals are advised to follow the outlined procedure for the application of the numbing cream prior to treatment.

Prior to application, it is essential to ensure that hands and the treatment area are thoroughly cleaned. This should be done using mild soap and warm water, followed by a thorough rinse and gentle patting dry.

A thick layer of the numbing cream should be applied to the treatment area, ensuring complete coverage of both the targeted area and its surrounding skin. After application, the area must be wrapped tightly with plastic wrap. It is recommended to allow the cream to remain in place for a duration of 40 to 60 minutes, as a longer duration may enhance the numbing effect.

Following the waiting period, the residue of the cream should be wiped away. It is advisable to wait an additional 15 to 25 minutes to allow the numbness to reach its peak effect before commencing the procedure.

Contraindications

Use of this product is contraindicated in individuals with known allergies to any of its ingredients, as this may lead to allergic reactions.

Additionally, the following instructions must be adhered to:

• Exceeding the recommended daily dosage is contraindicated unless specifically directed by a healthcare professional, due to the potential for adverse effects.

• Administration of this product via the rectum using a finger is contraindicated, as it may lead to complications or injury.

Warnings and Precautions

For external use only; contact with the eyes should be strictly avoided. In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately.

Patients are advised to discontinue use and consult a healthcare professional if they experience any adverse reactions or if they exceed the recommended daily dosage without medical guidance. It is important to note that some individuals may develop allergic reactions to the ingredients contained in this product. Monitoring for signs of such reactions is essential to ensure patient safety.

Side Effects

Patients should be advised that the product is for external use only and must be kept away from the eyes to prevent irritation or injury. Adverse reactions associated with the use of this product may occur, and it is important for patients to be aware of these potential effects.

In clinical trials and postmarketing experiences, specific adverse reactions have been reported, although detailed frequency data is not provided. Patients are encouraged to monitor for any unusual symptoms and to consult healthcare professionals if they experience any adverse effects.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Olelon Numbing (menthol). 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. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available about the potential for excretion 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 the use of this medication. Consequently, there are no 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 available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial for healthcare professionals to document the incident thoroughly, including the substance involved, the estimated dose, the time of exposure, and the clinical response to treatment. This information is vital for ongoing patient care and for any necessary reporting to regulatory authorities.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to manage potential overdose situations with a focus on supportive care and appropriate interventions.

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

Postmarketing experience has identified that certain individuals may develop allergic reactions to the ingredients in this product. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help immediately.

Patients should be informed not to exceed the recommended daily dosage unless directed by a healthcare professional. It is important for patients to understand that exceeding the dosage can lead to adverse effects.

Healthcare providers should also discuss the possibility of allergic reactions to the ingredients in this product. Patients should be encouraged to report any signs of an allergic reaction, such as rash, itching, or difficulty breathing, to their healthcare provider promptly.

Additionally, patients should be instructed not to insert this product into the rectum using their fingers, as this may lead to unintended complications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Any unused product should be discarded after opening if it is not utilized within the specified time frame, which is not detailed in the provided information.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients not to exceed the recommended daily dosage unless directed by a healthcare professional. It is important to inform patients that some individuals may experience allergic reactions to the ingredients in the product. Additionally, patients should be cautioned against inserting the product into the rectum using a finger.

Drug Information (PDF)

This file contains official product information for Olelon Numbing, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)