Pain Release

Description

Saje® Natural Wellness Pain Release is a topical analgesic oil blend designed for localized relief. This formulation is presented in a 1 fluid ounce (30 milliliters) container, providing a convenient dosage form for application. The product is specifically crafted to address discomfort through its blend of natural ingredients.

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 to administer it no more than three to four times daily. It is important to note that this medication is not recommended for use in children under 12 years of age.

Healthcare professionals should ensure that the dosing frequency does not exceed the specified limits to maintain safety and efficacy.

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 pose additional health risks.

These contraindications are established to ensure patient safety and prevent adverse 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.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center without delay.

Patients should 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. Monitoring of the patient's condition is essential to ensure appropriate management and intervention as needed.

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 stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. These precautions are essential to ensure the safety and efficacy of the treatment.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. 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 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age are not recommended to use this medication. For adolescents 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.

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 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 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

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 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 warranted based on clinical judgment.

Overdosage

In the context of overdosage, it is important to note that there is currently no specific information available regarding overdosage in the drug insert. Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose, even in the absence of detailed guidance.

In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any adverse effects or symptoms that may arise. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

Healthcare professionals are encouraged to report any cases of overdosage to the appropriate regulatory authorities to contribute to the ongoing assessment of the drug's safety profile.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients 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 to prevent adverse effects.

Patients should be cautioned against using the product if they have a history of epilepsy or high blood pressure, as these conditions may contraindicate its use. 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.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using the product. Patients should also be advised not to bandage the area tightly when using the product to ensure proper application and minimize the risk of complications.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to keep the product away from fire or flame to ensure safety. Healthcare professionals should also note that the product should not be used if the security seal around the bottle cap is broken or missing, as this may indicate potential tampering or contamination.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 12 years and older. 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)