Signature Care 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 aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is recommended to consult a physician prior to use. After application, hands should be washed thoroughly with cool water to prevent accidental contact with sensitive areas or ingestion.

Contraindications

The product is contraindicated for application to wounds or damaged skin, as this may exacerbate the condition. It should not be applied to irritated skin or in cases where excessive irritation develops, due to the potential for further skin damage. Additionally, tight bandaging or the use of heating pads or devices in conjunction with the product is contraindicated, as this may lead to adverse effects.

Warnings and Precautions

For external use only. This product must be kept away from fire or flame to prevent potential hazards.

It is imperative that the product is used only as directed. Healthcare professionals should advise patients to avoid contact with the eyes or mucous membranes, as this may lead to adverse effects. The product should not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops. Additionally, patients should be cautioned against tightly bandaging the area of application or using it in conjunction with heating pads or devices, as this may exacerbate irritation or lead to other complications.

In the event of accidental ingestion, immediate medical assistance should be sought by contacting the Poison Control Center at 1-800-222-1222.

Patients should be instructed to discontinue use and consult their healthcare provider if they experience any of the following: pain, swelling, or blistering of the skin; worsening of their condition; symptoms that persist for more than 7 days; or if symptoms clear up and then recur within a few days. Furthermore, if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age, medical advice should be sought promptly.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should be kept away from fire or flame to prevent any hazardous situations.

In the event of experiencing pain, swelling, or blistering of the skin, patients are advised to stop use and consult a doctor. Additionally, if the condition worsens, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, medical advice should be sought. Patients should also seek medical attention if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used in children under 12 years of age.

These precautions are essential to ensure the safety and well-being of patients while using this product.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Signature Care Menthol (menthol 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to rub a thin film over the affected area no more than 3 to 4 times daily. If the condition persists or worsens, or if it affects children under 12 years of age, it is advised to discontinue use and seek medical advice.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 on 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, no dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function are specified in the prescribing information. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific information.

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 elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed and to avoid contact with eyes or mucous membranes. Patients should be informed not to apply the medication to wounds or damaged skin, and to refrain from using it on irritated skin or if excessive irritation develops.

It is important to instruct patients not to bandage the area tightly or use the medication in conjunction with a heating pad or device. Patients should be made aware that if they experience pain, swelling, or blistering of the skin, they should stop use and consult a doctor.

Additionally, healthcare providers should counsel patients to seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be advised to stop use and consult a doctor if arthritic pain persists for more than 10 days, if redness is present, or if the medication is being used in children under 12 years of age.

Finally, patients should be instructed that if the medication is swallowed, they should seek medical help or contact the Poison Control Center at 1-800-222-1222 immediately.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 68-77°F (20-25°C). The storage location should be a cool, dry place, ensuring that the product is kept away from direct sunlight to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)