Pain Relief

Description

Extra Strength Pain Relief Spray is a topical formulation designed for fast-acting relief from backaches, sore muscles, and joint pain. Established in 1868, J.R. Watkins Remedies for Body™ incorporates natural menthol, arnica, and vitamin E to provide a cooling effect upon application. The product is packaged in a 4.0 fl oz (118 mL) container and is utilized by athletes for its effective pain relief properties.

Uses and Indications

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

Adults and children 12 years of age and older are instructed to apply the medication to the affected area no more than four times a day. The application should involve massaging the painful area until the product is fully absorbed into the skin. It is essential to wash hands thoroughly with cold water after each use to prevent accidental contact with sensitive areas.

For children under 12 years of age, it is recommended to consult a healthcare professional before use to ensure safety and appropriateness of treatment.

Contraindications

The product is contraindicated for use in the following situations:

• Application on open wounds, damaged, or irritated skin due to the potential for exacerbating the condition.

• Concurrent use with heating pads or TENS devices, as this may lead to increased risk of adverse effects.

• Co-administration with other topical products containing menthol, which may result in enhanced irritation or adverse reactions.

• Tight bandaging, which could restrict circulation and lead to complications.

• Contact with eyes or mucous membranes, as this may cause irritation or injury.

• Puncturing or incinerating the product, which poses safety hazards.

• Storage at temperatures exceeding 120°F, as this may compromise product integrity and efficacy.

Warnings and Precautions

For external use only, this product is flammable; therefore, it must be kept away from fire, flames, and heated surfaces. It is contraindicated for use on open wounds, damaged, or irritated skin. The application of this product in conjunction with heating pads or TENS devices is not recommended. Additionally, it should not be used alongside any other topical products, including creams, ointments, sprays, liniments, or other formulations containing menthol.

When applying this product, it is essential to avoid tight bandaging. Users must adhere strictly to the directions provided for use. Care should be taken to prevent contact with the eyes or mucous membranes, as this may lead to irritation.

The contents of this product are under pressure; therefore, it should not be punctured or incinerated. Storage should be maintained at temperatures not exceeding 120°F to ensure product integrity.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, sensitivity of the skin, development of rash, itching, redness, or excessive irritation. Additionally, if symptoms persist for more than seven days or if symptoms resolve and then recur within a few days, medical advice should be sought.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, development of sensitive skin, rash, itching, redness, or excessive irritation of the skin. Additionally, if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days, medical advice should be sought.

It is important to note that this product is for external use only. Patients should also be made aware that the product is flammable and should be kept away from fire, flame, and heated surfaces.

Drug Interactions

The use of this product is contraindicated in conjunction with other topical formulations that contain menthol, including creams, ointments, sprays, and liniments. Co-administration may lead to increased local irritation or adverse effects due to the cumulative menthol content.

No specific interactions with laboratory tests have been identified in the available data. Therefore, routine monitoring of laboratory parameters is not necessary when using this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor prior to use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area not more than four times a day.

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 consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 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, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

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 and to seek medical help or contact a Poison Control Center immediately if the product is swallowed. Patients should be instructed not to use the product on open wounds, damaged, or irritated skin, and to avoid using it in conjunction with a heating pad or TENS device.

It is important to inform patients that they should not use the product with any other creams, ointments, sprays, liniments, or topical products that contain menthol. Patients should be counseled to stop using the product and consult a doctor if their condition worsens, if they have sensitive skin, or if they experience rash, itching, redness, or excessive irritation of the skin. Additionally, patients should be advised to discontinue use and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

When using the product, patients should be reminded not to bandage tightly and to use it only as directed. They should also be cautioned to avoid contact with eyes or mucous membranes. Providers should inform patients that the product is under pressure and should not be punctured or incinerated. Lastly, patients should be advised to store the product at temperatures not exceeding 120 degrees Fahrenheit.

Storage and Handling

The product is supplied in packaging that ensures safety and integrity. It must be stored in a location that is inaccessible to children. The recommended storage conditions are dry and well-ventilated, maintaining a temperature range of 59 to 77 degrees Fahrenheit (15 to 25 degrees Celsius). Proper handling and storage are essential to preserve the product's quality and efficacy.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children aged 12 years and older should apply the product to the affected area no more than four times daily, massaging until fully absorbed, and washing hands with cold water after each use. For children under 12 years of age, consultation with a doctor is advised.

Clinicians should counsel patients on important safety information. The product is for external use only and is flammable; it should be kept away from fire, flames, and heated surfaces. Patients should avoid using it on open wounds, damaged or irritated skin, or in conjunction with heating pads, TENS devices, or other topical products containing menthol. It is crucial to avoid tight bandaging and contact with eyes or mucous membranes. Patients should discontinue use and consult a doctor if symptoms worsen, if sensitive skin reactions occur, or if symptoms persist beyond seven days. Pregnant or breastfeeding individuals should seek professional advice before use, and the product must be kept out of reach of children, with immediate medical attention sought if ingested.

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)