Pain Release

Description

Saje Natural Wellness Pain Release is a pain-relieving bath salt soak designed to provide relief from discomfort. The product is packaged in a net weight of 4.2 oz (120 g).

Uses and Indications

This drug is indicated for the treatment of affected areas in adults and children aged 12 years and older. The recommended administration involves dissolving 2 teaspoons of the salt soak in warm water and soaking the affected area.

Limitations of Use: There are no known 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. Healthcare professionals are advised to consult a physician prior to administering this medication to children under 12 years of age to ensure safety and appropriateness of treatment.

Contraindications

Use is contraindicated in patients with a history of epilepsy due to the potential for exacerbation of seizures. Additionally, the product should not be used in individuals with high blood pressure, as it may pose significant health risks.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with a history of epilepsy and those with high blood pressure.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the 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 obtain emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

The use of this medication is contraindicated in patients with a history of epilepsy due to the potential for exacerbating seizures. Additionally, it should not be administered to individuals with high blood pressure, as it may pose significant health risks.

There are no specific drug or laboratory test interactions reported for this medication. Therefore, no additional monitoring or dosage adjustments are necessary concerning drug or laboratory test 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

Children under 12 years of age should consult a doctor before use. For adults and children aged 12 years and older, the recommended application involves dissolving 2 teaspoons of salt in warm water and soaking the affected area no more than 3 to 4 times daily. It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 it is advised to avoid exposure to ensure the safety of both the mother and the fetus. Healthcare professionals should counsel women of childbearing potential regarding the importance of effective contraception during treatment and the need to discontinue use if pregnancy occurs.

Lactation

Lactating mothers are advised against the use of this product while breastfeeding. There is no available data on the excretion of the 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

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 these patients to ensure safety and efficacy.

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

There are currently no specific details available regarding overdosage for this medication (SPL code 34088-5). Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from potential overdosage. In the absence of documented overdosage information, it is recommended that clinicians follow standard protocols for managing overdose situations, which may include supportive care and symptomatic treatment as necessary.

In the event of suspected overdosage, healthcare providers should consider contacting a poison control center or seeking guidance from a medical toxicologist for further management recommendations.

Nonclinical Toxicology

If pregnant or breast-feeding, the use of this product is contraindicated due to potential teratogenic effects. There are no specific non-teratogenic effects or detailed nonclinical toxicology data available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed that the product is contraindicated for individuals with epilepsy and those with high blood pressure. It is essential to emphasize that if the patient's condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, they should stop using the product and consult a doctor.

Additionally, healthcare providers should remind patients to avoid contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in a secure packaging format, ensuring integrity and safety. It is essential to store the product in a cool, dry place to maintain its efficacy.

Healthcare professionals should verify that the Saje seal on the bottle's opening is intact before use. Additionally, the tear notch security seal on the zippered bag inside must be undamaged and present; if either seal is broken or missing, the product should not be used.

Additional Clinical Information

The product is administered topically. For adults and children aged 12 years and older, the recommended method involves dissolving 2 teaspoons of salt soak in warm water and soaking the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to 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 Pain Release, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)