Pain Release Joint and Arthritis Cream

Description

Pain Release Joint Cream is presented in a 10 ml dosage form. The product is contained within an outer box label that provides essential information regarding its use and application.

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 individuals aged 13 years and older, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily. It is essential to ensure that the application is performed on clean, dry skin to maximize efficacy. Care should be taken to avoid contact with eyes and mucous membranes.

Contraindications

The product is contraindicated for application to wounds or damaged skin, and it should not be bandaged tightly. Due to the potential for exacerbating the condition, discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. This product is for external use only; avoid contact with the eyes.

Warnings and Precautions

For external use only; contact with the eyes should be strictly avoided. Application of this product is contraindicated on wounds, damaged skin, or under tight bandages.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days.

It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product. It is intended for external use only, and contact with the eyes should be avoided. The product should not be applied to wounds or damaged skin, nor should it be bandaged tightly.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These precautions are critical to ensure patient safety and to prevent potential complications.

Overall, adherence to these guidelines is essential for minimizing adverse reactions and ensuring effective use of the product.

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 Pain Release Joint and Arthritis Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. For individuals aged 13 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. There are no specific dosage recommendations or study outcomes provided for younger pediatric populations. Caution is advised when administering this product to children.

Geriatric Use

Elderly patients, defined as those aged 65 and older, should be monitored closely when using this medication. The recommended application frequency for this population is not more than 3-4 times daily to the affected area.

Due to the potential for altered pharmacokinetics and increased sensitivity in geriatric patients, healthcare providers should exercise caution and consider individual patient factors when determining the appropriate dosage and frequency of application. Regular assessment of the treatment's efficacy and safety is advised to ensure optimal therapeutic outcomes in this demographic.

Pregnancy

There is currently no information available regarding the use of PAIN RELEASE JOINT AND ARTHRITIS CREAM during pregnancy. As such, 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 versus benefits before recommending this product during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available 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.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider 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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, 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 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 to prevent accidental ingestion or misuse. Patients should be instructed not to apply the product to wounds, damaged skin, or to bandage the area tightly after application, as this may lead to adverse effects.

It is important for healthcare providers to inform patients that the product is for external use only and to avoid contact with the eyes. Patients should be counseled to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if the symptoms clear up and then occur again within a few days. This guidance will help ensure safe and effective use of the product.

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 room temperature, ensuring that it is protected from light to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

For individuals aged 13 and older, the medication should be applied to the affected area no more than 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)