Pain Relief Roll on

Description

J.R. Watkins Extra Strength Roll-On is a topical formulation designed for fast-acting pain relief. Established in 1868, this product is formulated with natural menthol, arnica, and vitamin E, providing a cooling effect that targets backaches, sore muscles, and joint pain. The roll-on dosage form allows for convenient application, making it suitable for use by athletes. Each container has a net weight of 2.8 oz (79 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 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 unexpected reactions.

• Tight bandaging of the treated area is contraindicated to prevent compromised circulation.

• Contact with eyes or mucous membranes should be avoided to prevent irritation or injury.

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.

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, medical consultation is warranted.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

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. 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.

Drug Interactions

Co-administration of this product with other topical formulations containing menthol, such as creams, ointments, sprays, or liniments, is contraindicated. The combination may lead to increased local irritation or adverse effects due to the overlapping mechanisms of action.

There are no specific interactions identified with laboratory tests associated with this product. Therefore, no adjustments or special monitoring are required in relation to laboratory testing.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional 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 efficacy, 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. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 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 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 and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on open wounds, damaged, or irritated skin. It is important to inform patients that the product should not be used in conjunction with heating pads or TENS devices, nor should it be combined with any other creams, ointments, sprays, liniments, or topical products that contain menthol.

Patients should be made aware that they need 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. Additionally, they should be advised to seek medical advice if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

When using the product, patients should be cautioned against bandaging the area tightly and should use the product only as directed. It is also essential to remind patients to avoid contact with their eyes or mucous membranes while using this product.

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 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.

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

Drug Information (PDF)

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

View product document (PDF)