Pain Relief

Description

This topical analgesic is a pain-relieving spray formulated in a 4 fluid ounce (118.3 mL) dosage form. The active ingredient, menthol, is present at a concentration of 7%. The formulation also includes eucalyptus oil, glycerin, isopropyl alcohol, wintergreen oil, purified water, and tea tree oil. The product is manufactured by Pain Relieving Spray Inc., located in Bend, Oregon 97702-1971.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

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

Dosage and Administration

For adults and children aged 2 years and older, the product should be shaken well before use. It is to be applied to the affected area no more than 3 to 4 times daily.

In the case of children under 2 years of age, it is advised to consult a healthcare professional prior to administration.

Contraindications

The product is contraindicated for application to open wounds or damaged skin due to the potential for irritation and adverse reactions. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

This product is intended for external use only and is classified as flammable. It is imperative to keep the product away from open flames and other sources of ignition to prevent fire hazards.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is recommended. Care should be taken to avoid contact with the eyes, as this may lead to irritation or injury.

Application of this product is contraindicated on open wounds or damaged skin. Additionally, it is advised not to bandage the area tightly after application, as this may exacerbate potential adverse effects.

Healthcare professionals should be vigilant for signs of excessive skin irritation. Patients with a known history of allergic reactions to salicylates, including aspirin, should consult a physician prior to use. If the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and medical advice should be sought.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that the product is for external use only and is flammable; therefore, it should be kept away from flames.

In the event of accidental ingestion, patients should seek medical assistance or contact a poison control center immediately. Additionally, care should be taken to avoid contact with the eyes. The product should not be applied to open wounds or damaged skin, and it is advised not to bandage the area tightly.

Patients are encouraged to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. If the condition worsens, or if symptoms persist for more than 7 days or clear up and recur within a few days, discontinuation of the product and consultation with a healthcare professional is recommended.

To ensure safety, this product should be kept out of reach of children.

Drug Interactions

Patients with a known hypersensitivity to salicylates, including aspirin, should consult a healthcare professional prior to initiating treatment. This precaution is essential to mitigate the risk of allergic reactions.

No specific interactions with other drugs or laboratory tests have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not indicated at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may use the product by shaking well and applying it to the affected area no more than 3-4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that there is no specific information regarding the use of this product during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when using this product while breastfeeding.

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 this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, it is imperative to seek medical help or contact a poison control center without delay.

Healthcare professionals should be aware that exposure to the substance may lead to various symptoms, although specific symptoms are not detailed in the provided information. Therefore, monitoring the patient for any adverse reactions is essential.

Additionally, it is important to avoid contact with the eyes, as this may exacerbate the situation or lead to further complications. Proper precautions should be taken to prevent any exposure during the management of an overdosage case.

In summary, prompt action and adherence to safety protocols are vital in managing overdosage incidents effectively.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 emphasize the need to avoid contact with the eyes to prevent irritation.

Patients should be instructed not to apply the product to open wounds or damaged skin and to avoid tight bandaging of the area where the product is applied.

Providers should encourage patients to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Additionally, patients should be informed that if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use of the product and seek medical advice.

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 to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)