Pain Relief

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of joints and muscles 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 adults and children aged 12 years and older, the recommended dosage is to spray the product onto the affected area no more than 3 to 4 times daily. It is not necessary to massage the area after application.

For children under 12 years of age, it is advised to consult a physician prior to use.

After application, it is important to wash hands thoroughly with cool water to prevent any unintended contact with other areas of the body or surfaces.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. It should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. Additionally, tight bandaging or the use of heating pads or devices in conjunction with the product is contraindicated, as it may lead to increased risk of irritation or other complications. Contact with the eyes or mucous membranes must be avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. The product is under pressure; therefore, it must not be punctured or incinerated. It is flammable and should be kept away from excessive heat or open flame. Storage should not exceed temperatures of 120ºF to ensure safety and efficacy.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Patients should discontinue use and consult a healthcare professional if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; or if symptoms persist for more than 7 days or resolve only to recur within a few days. Additionally, if arthritic pain continues for more than 10 days or if redness is observed, medical advice should be sought promptly.

Emergency medical help is essential if the product is swallowed, necessitating immediate contact with a medical professional or Poison Control Center.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only. The contents are under pressure, and therefore, it should not be punctured or incinerated. Additionally, the product is flammable; it is crucial to keep it away from excessive heat or open flame. Storage should not exceed temperatures of 120ºF to ensure safety and efficacy.

In the event of adverse reactions, patients are advised to stop use and consult a doctor if they experience pain, swelling, or blistering of the skin. If the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, medical advice should be sought. Furthermore, if arthritic pain persists for more than 10 days or if redness is present, it is recommended to seek medical attention.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted 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 under 12 years of age should consult a physician prior to use. For adolescents and adults aged 12 years and older, the recommended dosage is to spray on the affected area no 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure appropriate management during pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 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 regarding its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions thoroughly, as this information may be vital for ongoing patient management and for any necessary reporting to regulatory authorities.

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 the reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be informed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For those experiencing arthritic pain, it is important to inform them to stop use and consult a doctor if the pain persists for more than 10 days or if redness is present.

When using this product, patients must be reminded to follow the directions carefully. They should avoid contact with the eyes and mucous membranes, and not apply the product to wounds or damaged skin. Patients should also be cautioned against using the product on irritated skin or if excessive irritation develops. Furthermore, they should not bandage the area tightly or use it in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20ºC to 25ºC (68ºF to 77ºF). Additionally, it is essential to keep the product in a dry place, ensuring it is protected from direct sunlight to maintain its integrity and efficacy. Special handling requirements should be observed to prevent exposure to conditions that may compromise the product's quality.

Additional Clinical Information

The medication is administered topically, with a recommended frequency of application for adults and children aged 12 years and older being no more than 3 to 4 times daily to the affected area. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)