Menthol Pain Relief Gel-Roll on

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of muscle soreness and minor joint pains. It is specifically effective for discomfort in the wrist, knees, ankles, back, neck, hips, shoulders, and elbows.

Limitations of Use: This product is intended for short-term use and should not be used as a substitute for professional medical advice or treatment for underlying conditions.

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply a thin film of the medication over the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 12 years of age, consultation with a physician is recommended prior to use.

After application, it is essential to wash hands thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

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 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. This product is contraindicated for application on wounds or damaged skin. It should not be used in conjunction with heating pads or devices, nor should it be combined with other ointments, creams, sprays, or liniments. Individuals with known allergies to any ingredients in this product should refrain from use.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any skin reactions occur, including but not limited to redness, swelling, blistering, or other discomfort. Additionally, if symptoms persist beyond 7 days, patients should be instructed to stop using the product and consult their healthcare provider.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. In clinical practice, some participants have reported skin reactions, including redness, swelling, blistering, or other 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 for further evaluation and guidance. These precautions are essential to ensure the safety and well-being of individuals using the product.

Drug Interactions

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical products may lead to altered absorption, increased risk of local irritation, or diminished therapeutic efficacy. It is advised to avoid concurrent use to ensure optimal treatment outcomes and minimize potential adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol Pain Relief Gel-Roll on (menthol). 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

There is no specific information available 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, 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 understanding of the potential toxicological profile 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 to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to apply a thin film of the medication over the affected areas up to four times daily, without the need for massage. For children under 12 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important to instruct patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally swallowed.

Drug Information (PDF)

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

View product document (PDF)