Menthol Roll on

Description

The product is identified by SPL code 34089-3 and 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 microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The product is supplied in bottles containing 100 tablets.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older. It is to be applied as a thin film over the affected areas, not exceeding four applications per day. For children under 12 years of age, consultation with a physician is recommended prior to use.

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

Dosage and Administration

The recommended dosage is 74 mL per bottle. Healthcare professionals should ensure that the entire contents of the bottle are administered as directed. Specific routes, methods, and frequency of administration have not been provided; therefore, it is essential to refer to additional guidelines or clinical protocols for further details on administration techniques and timing.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the potential for adverse effects.

• Concurrent use with heating pads or devices is not recommended, as it may lead to increased risk of burns or skin irritation.

• The product should not be combined with other ointments, creams, sprays, or liniments, as this may alter its efficacy or safety profile.

• Individuals with known allergies to any ingredients in this product should refrain from use to avoid allergic reactions.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental swallowing, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare providers should monitor patients for any adverse skin reactions. If patients experience symptoms such as redness, swelling, blistering, or any other discomfort, they should discontinue use of the product and consult their physician. Additionally, if symptoms persist for more than 7 days, it is essential for patients to stop using the product and seek medical advice.

Side Effects

Patients using this product should be aware that it is intended for external use only. In clinical trials and postmarketing experiences, skin reactions have been reported, including redness, swelling, blistering, and other forms of discomfort. If any of these reactions occur, patients are advised to stop using the product immediately.

Additionally, if symptoms persist for more than 7 days, it is recommended that patients consult a healthcare professional. These precautions are essential to ensure the safety and well-being of individuals using the product.

Drug Interactions

The use of this medication is contraindicated with other topical formulations, including ointments, creams, sprays, or liniments. Co-administration may lead to altered efficacy or increased risk of adverse effects due to overlapping mechanisms of action or compounded irritative effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not required in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol Roll on (pain relief gel). 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 and children aged 12 years and older, the recommended dosage is to apply a thin film over the affected areas no more than four times daily.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 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 absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive measures. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following excessive administration of the product.

Management Procedures In the absence of detailed guidance, standard protocols for managing drug overdosage should be followed. This may include gastric decontamination, administration of activated charcoal if appropriate, and supportive care tailored to the patient's needs. Consultation with a poison control center or a medical toxicologist is recommended for further guidance in managing suspected overdosage cases.

Healthcare professionals are encouraged to report any overdosage incidents to the relevant authorities to contribute to the ongoing assessment of the product's safety profile.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed to ensure safety and efficacy. Instruct patients to avoid contact with the eyes, mucous membranes, or any rashes, as this may lead to irritation or adverse effects.

In the event of accidental ingestion, patients should be informed to seek medical help or contact the Poison Control Center immediately. Additionally, it is important to counsel patients against applying a tight bandage over the treated area, as this may interfere with the medication's effectiveness and increase the risk of side effects.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to ensure optimal stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

Patients should apply a thin film of the medication over the affected areas, not exceeding four times daily. Massage of the area is not necessary for effective use. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children; if ingested accidentally, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)