Atopalm Pain Relieving

Description

This pain relieving cream is formulated for nighttime use, featuring a non-greasy and non-staining composition. It contains 10% menthol, providing deep penetrating pain relief. The cream is specially formulated with US patented MLE technology, ensuring effective delivery of its active ingredients. It has an ultra-light nighttime scent and is designed to apply smoothly, leaving the skin feeling soft and smooth. The product is packaged in a net weight of 2 oz (57 g) and is branded under ATOPALM™.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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 dosage is to apply the medication to the affected area no more than 3 to 4 times daily.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing instructions.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with eyes or mucous membranes should be strictly avoided due to the potential for irritation or adverse reactions. Additionally, the product should not be applied with tight bandaging, as this may lead to increased absorption and potential systemic effects.

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. Additionally, it is not recommended for use in children under 12 years of age who present with arthritis-like conditions.

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

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, excessive skin irritation, or the presence of redness over the affected area. Monitoring for these signs is essential to ensure patient safety and effective management of treatment.

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 not be applied to wounds or damaged skin. Additionally, it is contraindicated for use with a heating pad and should not be used on children under 12 years of age who have arthritis-like conditions.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, if excessive skin irritation develops, or if there is noticeable redness over the affected area. These precautions are essential to ensure the safety and well-being of patients using this product.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Pain Relieving (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

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

Geriatric Use

There is no specific information regarding the use of AtopalM Pain Relieving Cream in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor for any potential adverse effects or changes in efficacy, as older adults may have different pharmacokinetic and pharmacodynamic responses compared to younger populations.

Given the absence of targeted studies or data on geriatric use, clinicians should consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriateness of AtopalM Pain Relieving Cream for elderly patients.

Pregnancy

There is currently no information available regarding the use of ATOPALM PAIN RELIEVING menthol cream during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution and consider the lack of data when prescribing this product to women who are pregnant or may become pregnant. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

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

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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 compound in these areas.

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. Instruct patients that if the product is swallowed, they should seek medical help immediately or contact a Poison Control Center without delay.

Patients should be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be advised to stop using the product and seek medical advice if symptoms resolve but then recur within a few days.

It is important to counsel patients to stop use and consult a healthcare professional if they experience excessive skin irritation or notice redness over the affected area. Furthermore, patients should be reminded to avoid contact with eyes or mucous membranes while using this product and to refrain from tightly bandaging the area of application.

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 20 to 25 degrees Celsius (68 to 75 degrees Fahrenheit) to ensure optimal stability and efficacy.

Healthcare professionals are advised to check the carton, flap, or tube crimp for the lot number and expiration date to ensure proper tracking and usage of the product. Special handling requirements are not specified; however, maintaining the recommended storage conditions is essential for preserving product integrity.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 12 years and older being no more than 3 to 4 times daily to the affected area. 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 experience.

Drug Information (PDF)

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

View product document (PDF)