Mrkayll Numbing Cream

Description

The drug is presented in accordance with its principal display panel. The effective date for the drug is July 22, 2025. Additionally, the insert contains a reference to an image labeled "Menthol Percent.jpg," which may provide further information regarding the formulation or concentration of menthol in the product.

Uses and Indications

This drug is indicated for the temporary alleviation of localized discomfort, pruritus, pain, or burning sensation in the perianal area associated with anorectal disorders.

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

Dosage and Administration

For children under 12 years of age, it is recommended to consult a healthcare professional prior to use.

For adults, the following steps should be adhered to for proper application of the product:

1. If feasible, cleanse the affected area using mild soap and warm water, ensuring thorough rinsing to remove any residue.

2. Gently pat the area dry using toilet tissue or a soft cloth to avoid irritation.

3. The product may be applied up to four times daily, as needed.

Healthcare professionals should ensure that patients are aware of these instructions to optimize the effectiveness of the treatment.

Contraindications

Use of this product is contraindicated in the following situations:

Pregnancy and Breastfeeding The product should not be used in pregnant or breastfeeding individuals due to potential risks to the fetus or infant.

Allergy to Ingredients Individuals with a known allergy to any of the ingredients in this product should avoid its use to prevent allergic reactions.

Recommended Dosage Exceeding the recommended daily dosage is contraindicated unless directed by a healthcare professional, as it may lead to adverse effects.

Rectal Insertion Inserting this product into the rectum using fingers, medical devices, or applicators is contraindicated to avoid potential injury or complications.

Accidental Overdose In the event of an accidental overdose, immediate medical assistance should be sought, or the poison control center should be contacted.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes. In the event of accidental ingestion, immediate medical attention is required.

It is essential to exercise caution when recommending this product to individuals who are pregnant or breastfeeding. Patients should be instructed to consult a healthcare professional prior to use if they have a known allergy to any component of this product. In cases of accidental overdose, patients must seek medical assistance or contact a poison control center without delay.

Patients should be advised to discontinue use and consult their healthcare provider if discomfort persists for more than 7 days, or if the symptoms being treated do not improve. Additionally, they should seek medical advice if any redness, irritation, swelling, pain, or other adverse symptoms develop or worsen.

In the event of an accidental overdose, immediate medical help should be sought, or the poison control center should be contacted right away.

Side Effects

Patients should be aware that the product is intended for external use only. In the event that discomfort persists for more than 7 days, or if the symptoms being treated do not subside, it is advised to stop use immediately. Additionally, patients should seek medical advice if they experience any increase in redness, irritation, swelling, pain, or other symptoms during treatment. These recommendations are crucial to ensure patient safety and to mitigate any potential adverse reactions associated with the use of the product.

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 Mrkayll Numbing Cream (menthol 1% numbing cream). 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. This recommendation is crucial to ensure appropriate evaluation and guidance regarding the safety and efficacy of the treatment in this age group.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this medication. It is essential for women of childbearing potential to consult a healthcare professional prior to use to discuss potential risks and benefits. The safety of this medication during pregnancy and lactation has not been established, and its use is contraindicated in these populations.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. It is important for lactating mothers to consult a healthcare professional prior to use to ensure the safety of both the mother and the breastfed infant.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential for healthcare professionals to regularly monitor the renal function of these patients to ensure safe and effective treatment. Assessment of creatinine clearance is critical in determining the appropriate dosing regimen. Additionally, special considerations should be taken into account for patients with severe renal impairment to mitigate potential risks associated with therapy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact the poison control center. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the safety and well-being of the patient.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or breastfeeding individuals. It is advised to consult a health professional prior to use.

No non-teratogenic effects have been provided in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to avoid contact with the eyes when using this product. In the event of accidental ingestion, patients should seek medical attention immediately.

Patients must be informed about the importance of adhering to the recommended daily dosage and should not exceed this dosage unless directed by a healthcare professional. In cases of accidental overdose, it is crucial to obtain medical help or contact the poison control center without delay.

Additionally, healthcare providers should instruct patients to avoid inserting the product into the rectum using fingers, medical devices, or applicators, as this may lead to complications.

Finally, patients should be cautioned against using the product if they have a known allergy to any of its ingredients or if the product's seal is broken or missing, as this could pose health risks.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 59°F to 86°F (15°C to 30°C). Care should be taken to keep the product away from direct sunlight and heat to maintain its integrity and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of up to four times daily. Clinicians should counsel patients against use during pregnancy or breastfeeding and advise them to consult a healthcare professional if they experience any allergic reactions. It is important to instruct patients to avoid inserting the product into the rectum using fingers, medical devices, or applicators.

Additionally, patients should be reminded to keep the product out of reach of children and to avoid contact with the eyes. In the event of accidental ingestion, immediate medical attention should be sought. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)