Pain Relief

Description

J.R. Watkins Remedies for Body™ offers extra-strength cooling pain relief patches, established in 1868. Each patch contains 7.5% natural menthol, designed to provide fast-acting cooling relief for backaches, sore muscles, and joint pain. The patches are crafted to deliver lasting pain relief through a mess-free application, making them suitable for use by athletes. Each patch measures 5.51 inches by 3.94 inches (14 cm x 10 cm) and is individually packaged, with a total of five patches per box.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints due to conditions such as arthritis, simple backache, strains, sprains, and bruises.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to gently fold the patch in half and remove one side of the backing. The exposed adhesive should be applied directly to the site of pain. After securing the patch in place, the remaining film from the other side should be removed to complete the application to the skin. The patch may be used on affected areas for a maximum duration of 12 hours.

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

Contraindications

The use of this product is contraindicated in patients who are concurrently using any other creams, ointments, sprays, liniments, or topical products containing menthol, due to the potential for increased irritation or adverse effects.

Additionally, caution is advised to avoid contact with the eyes and mucous membranes, as this may lead to irritation. The product should not be applied to wounds or damaged skin, as this could exacerbate the condition or lead to further complications. Furthermore, it is contraindicated to bandage tightly or use a heating pad in conjunction with this product, as this may increase the risk of skin irritation or other adverse reactions.

Warnings and Precautions

For external use only. Prior to application, individuals with sensitive skin should consult a healthcare professional.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Users must avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, it is advised not to bandage the area tightly or apply a heating pad.

In the event of excessive redness or irritation, or if the condition worsens, it is essential to discontinue use and seek medical advice. Users should also stop using the product if pain persists for more than 7 days, or if symptoms resolve and then recur within a few days.

This product should not be used concurrently with any other creams, ointments, sprays, liniments, or topical products that contain menthol, as this may lead to adverse effects.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important to consult a healthcare professional prior to use if the patient has sensitive skin.

When using this product, it is crucial to adhere strictly to the directions provided. Patients should avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, patients are advised against tightly bandaging the area of application or using a heating pad concurrently.

Patients should discontinue use and seek medical advice if they experience excessive redness or irritation, if their condition worsens, if pain persists for more than 7 days, or if symptoms resolve only to recur within a few days.

The product should not be used in conjunction with any other creams, ointments, sprays, liniments, or topical products that contain menthol.

It is also essential 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.

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 cumulative effects of menthol. It is advised to avoid using these products concurrently to ensure patient safety and minimize the risk of adverse reactions.

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 12 years of age and younger should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment in this age group to ensure safety and efficacy.

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 not use this medication, as it is contraindicated during pregnancy. The potential risks associated with the use of this medication in pregnant individuals may pose significant concerns for fetal outcomes. Healthcare professionals are advised to counsel women of childbearing potential regarding the importance of avoiding this medication if they become pregnant or are planning to become pregnant.

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

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.

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 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 available information.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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 keep the 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 this product in conjunction with any other creams, ointments, sprays, liniments, or topical products that contain menthol, as this may lead to adverse effects.

Providers should counsel patients to discontinue use and consult a doctor if they experience excessive redness or irritation, if their condition worsens, if pain persists for more than 7 days, or if symptoms resolve and then recur within a few days.

When using the product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes, and should not apply the product to wounds or damaged skin. Additionally, patients should be cautioned against tightly bandaging the area or using a heating pad in conjunction with the product.

Finally, healthcare providers should encourage patients to consult a doctor before use if they have sensitive skin, to ensure safe and effective use of the product.

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 in a cool and dry place to maintain its integrity. Care should be taken to protect the product from excessive moisture, as this can compromise its quality. Additionally, the product must not be refrigerated or frozen, as these conditions may adversely affect its efficacy. Proper handling and storage are crucial to ensure optimal performance and safety.

Additional Clinical Information

The medication is administered topically, with a recommended application for adults and children aged 12 years and older on affected areas for a duration of up to 12 hours. There are no additional details available regarding laboratory tests, abuse information, patient counseling, 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)