Atopalm Muscle and Joint

Description

This pain-relieving gel is formulated to provide deep relief for minor arthritis pain, sore and aching muscles, strained muscles, and simple backaches. It utilizes a moisturizing gel base that incorporates US Patented MLE Technology, ensuring effective pain relief while maintaining skin hydration. The active ingredient, menthol, is present at a concentration of 2.5%. The product features a vanishing scent, making it suitable for daytime use without lingering odors. Each container holds a net weight of 4 oz (113 g) and is marketed under the ATOPALM™ brand as a muscle and joint gel.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as 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 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to administration.

For children under 12 years of age, it is advised to consult a physician before use to determine the appropriate dosage and administration guidelines.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to wounds or damaged skin due to the risk of exacerbating the injury or causing infection. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to excessive heat and potential skin damage. Furthermore, it is not recommended for use in children under 12 years of age who present with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. It is also not recommended for use in children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area.

During the application of this product, it is crucial to avoid contact with the eyes and mucous membranes. Additionally, patients should be instructed not to apply tight bandages over the treated area.

Patients must be advised to discontinue use and seek medical advice if the condition worsens, if symptoms persist beyond 7 days, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

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

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only and should not be applied to wounds or damaged skin. Additionally, it should not be used in conjunction with a heating pad or on children under 12 years of age with arthritis-like conditions.

Participants are advised to consult a healthcare professional before use if there is any redness over the affected area. While using this product, it is crucial to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area.

Patients should discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if excessive skin irritation develops.

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 Atopalm Muscle and Joint (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional prior to use.

For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of ATOPALM MUSCLE AND JOINT menthol gel in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this product to elderly patients. It is advisable to monitor for any potential adverse effects or changes in efficacy, as the pharmacokinetics and pharmacodynamics may differ in this population. Additionally, clinicians should consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriateness of this treatment for geriatric patients.

Pregnancy

There is no information available regarding the use of ATOPALM MUSCLE AND JOINT menthol gel during pregnancy. Consequently, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before prescribing this product to pregnant patients.

Lactation

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

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Additionally, contacting a poison control center can provide valuable guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective treatment 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 assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to emphasize that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should counsel patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

While using the product, patients should be cautioned to avoid contact with their eyes or mucous membranes. They should also be instructed not to bandage the area tightly. Finally, healthcare providers should recommend that patients consult a doctor before use if there is redness over the affected area.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 68 to 77 degrees Fahrenheit (20 to 25 degrees Celsius) to ensure optimal stability and efficacy.

Healthcare professionals are advised to check the end of the carton or the tube crimp for the lot number and expiration date, which are essential for tracking and quality assurance. Proper handling and storage conditions are crucial to maintain the integrity of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Atopalm Muscle and Joint, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)