Menthol

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor muscle and joint pain associated with conditions such as arthritis, simple backache, muscle strains, sprains, and bruises.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended application is to the affected area no more than 3 to 4 times daily. It is essential to ensure that the medicine is applied as directed to maximize its effectiveness while minimizing the risk of adverse effects.

In the event that the medicine comes into contact with the hands, it is imperative to wash the hands thoroughly with soap and water to prevent unintended exposure or transfer of the medication.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

When using this product, it is imperative to adhere strictly to the directions provided. The product should not be applied with tight bandaging or in conjunction with a heating pad. Care should be taken to avoid contact with the eyes and mucous membranes. It is contraindicated to apply the product to wounds or to areas of damaged, broken, or irritated skin. Should any pain, swelling, or blistering occur at the site of application, the use of the product must be discontinued immediately, and professional medical attention should be sought.

In the event of accidental ingestion, it is crucial to obtain emergency medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult their physician if they experience any adverse skin reactions, such as pain, swelling, or blistering, at the site where the topical muscle and joint pain reliever was applied. These reactions necessitate immediate medical evaluation to prevent further complications.

Side Effects

Patients using the topical muscle and joint pain reliever should be aware of potential adverse reactions. Serious reactions may occur, including pain, swelling, or blistering of the skin at the site of application. If any of these symptoms develop, patients are advised to discontinue use immediately and seek professional medical attention.

In addition to serious reactions, there are important precautions to consider. Patients should avoid contact with eyes and mucous membranes to prevent irritation. Furthermore, the product should not be applied to wounds or to damaged, broken, or irritated skin, as this may exacerbate adverse effects or lead to further complications.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hot/Cold Menthol 16% Roll-on. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 12 years of age may apply the medication to the affected area no more than 3 to 4 times daily. It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients to ensure safety and therapeutic effectiveness.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is vital to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. It is imperative to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children over 12 years of age. Clinicians should advise patients to wash their hands with soap and water if the medicine comes into contact with them.

Patients are instructed to use the product only as directed, avoiding tight bandaging or the use of heating pads. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin. If patients experience pain, swelling, or blistering at the application site, they should discontinue use and seek professional medical attention. Additionally, the product should be kept out of reach of children, and if ingested, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Hot/Cold Menthol 16% Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)