Pain Release

Description

Pain Release Topical Analgesic Massage Oil is a product developed by Saje Natural Wellness. It is available in three dosage forms: 1.4 fl. oz (40 ml), 3.4 fl. oz (100 ml), and 6.8 fl. oz (200 ml). This topical analgesic is designed for application to the skin to provide relief from pain through massage.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older.

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

Dosage and Administration

The recommended dosage for the medication is not to exceed 3 to 4 times daily. For children under 12 years of age, it is imperative to consult a healthcare professional prior to administration to determine the appropriate dosage and ensure safety.

Healthcare professionals should assess the individual needs of the patient and adjust the frequency of administration accordingly, while adhering to the maximum dosage limits. Proper evaluation and guidance are essential for pediatric patients to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition and causing further injury.

• The product should not be used in individuals with epilepsy, as it may trigger seizures.

• Patients with high blood pressure should avoid this product, as it may lead to adverse cardiovascular effects.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

General precautions should be observed when using this product. It is contraindicated for application on wounds or damaged skin. Additionally, individuals with epilepsy should refrain from using this product. Caution is advised for those with high blood pressure, as the use of this product may not be appropriate.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from fire or flame.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are essential to ensure safety and effective management of their condition.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Release (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this product. The potential risks associated with the use of this product during pregnancy or lactation have not been established, and its safety in these populations has not been evaluated. Therefore, healthcare professionals are advised to consider alternative treatments for women who are pregnant or nursing.

Lactation

Lactating mothers are advised against the use of this product during breastfeeding. There is no available data on the excretion of this product in human milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for lactating mothers.

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 context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that standard supportive measures be employed. This may include symptomatic treatment and monitoring of vital signs. If an overdose is suspected, healthcare providers should consider contacting a poison control center or seeking expert consultation for further guidance on management strategies.

As always, maintaining a thorough understanding of the patient's medical history and current medications is essential in addressing any potential complications arising from an overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, the use of this product is contraindicated due to potential teratogenic effects. There are no specific non-teratogenic effects or additional nonclinical toxicology details provided. Furthermore, no specific information regarding animal pharmacology and toxicology has been documented.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to wounds or damaged skin. Additionally, patients with a history of epilepsy should be cautioned against using this product, as well as those with high blood pressure.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should also be reminded to avoid contact with the eyes while using this product. Furthermore, it is essential to advise patients not to bandage the area tightly when using the product to ensure safety and effectiveness.

Storage and Handling

The product is available in various packaging configurations, with specific NDC numbers provided for identification. It is essential to store the product under appropriate conditions to maintain its integrity and efficacy.

The recommended storage temperature range is between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). The product should be kept in its original container to protect it from light and moisture.

Healthcare professionals are encouraged to handle the product with care and to follow all applicable guidelines for safe storage and disposal. Additionally, the organization supports recycling initiatives and encourages the recycling of packaging materials where possible.

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 prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)