Pain Relief

Description

Extra Strength Pain Relief Gel is a topical formulation designed for fast-acting relief from backaches, sore muscles, and joint pain. This product, established in 1868 by J.R. Watkins, features a blend of natural menthol, arnica, and vitamin E, providing a cooling effect upon application. The gel is packaged in a no-mess applicator for ease of use and is suitable for athletes seeking effective pain management. Each container holds a net weight of 4.0 oz (113 g).

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 on open wounds, damaged, or irritated skin due to the potential for exacerbating the condition. Additionally, concurrent use with a heating pad or TENS device is not recommended, as it may lead to increased irritation or adverse effects. The application of this product alongside other topical formulations containing menthol is also contraindicated, as it may result in enhanced local irritation or unintended effects.

Warnings and Precautions

For external use only, this product is flammable; therefore, it must be kept away from fire, flames, and heated surfaces to prevent any risk of ignition.

General precautions should be observed during use. It is essential not to bandage the area tightly, as this may lead to complications. The product should be used strictly as directed, and contact with the eyes or mucous membranes must be avoided to prevent irritation or injury.

In the event of accidental ingestion, it is critical to keep the product out of reach of children. Immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: worsening of the condition, development of a 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, patients should be instructed to consult their doctor.

Side Effects

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, development of a rash, itching, redness, or excessive irritation of the skin, persistence of symptoms for more than 7 days, or if symptoms resolve and then recur within a few days.

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, patients should keep it away from fire, flames, and heated surfaces.

Drug Interactions

The use of this product is contraindicated with other topical formulations that contain menthol, including creams, ointments, sprays, liniments, or any similar products. Co-administration may lead to increased risk of adverse effects or diminished therapeutic efficacy due to overlapping mechanisms of action.

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 before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than four times a day.

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 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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication 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 this drug. 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In all cases of suspected overdosage, the involvement of poison control experts can provide valuable guidance on the appropriate management strategies tailored to the specific circumstances of the case.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: rash, itching, redness, and excessive irritation of the skin.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on open wounds, damaged, or irritated skin. It is important to emphasize that the product should not be used in conjunction with a heating pad or TENS device, nor should it be combined with any other creams, ointments, sprays, liniments, or topical products containing menthol.

Healthcare providers should counsel patients to stop using the product and consult a doctor if their condition worsens, or if they experience rash, itching, redness, or excessive irritation of the skin. Patients should also be advised to 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 instructed not to bandage tightly and to use the product only as directed. Additionally, they should avoid contact with eyes or mucous membranes to prevent irritation.

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 in a dry, well-ventilated area at room temperature, specifically between 59°F and 77°F. Proper handling and storage are essential to maintain the product's efficacy and safety.

Additional Clinical Information

The medication 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, ensuring to massage the painful area until fully absorbed into the skin. It is important for patients to wash their hands with cold water after each application. For children under 12 years of age, consultation with a doctor is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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)